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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01871727
Registration number
NCT01871727
Ethics application status
Date submitted
28/03/2013
Date registered
7/06/2013
Date last updated
13/11/2024
Titles & IDs
Public title
A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
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Scientific title
A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma
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Secondary ID [1]
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E7777-G000-302
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Persistent or Recurrent Cutaneous T-Cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - E7777 9 mcg/kg
Experimental: E7777 -
Treatment: Drugs: E7777 9 mcg/kg
administered by intravenous (i.v.) infusion over 60 minutes (+/-10 minutes) on 5 consecutive days during every cycle of 21 days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03)
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Assessment method [1]
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DLTs as per NCI CTCAE v4.03 were defined as 1) serious infusion reaction (CTCAE) Grade 4 adverse event of "Infusion related reaction," or recurrent CTCAE Grade 3 despite administration of systemic steroid premedication after initial occurrence. Infusion reactions were defined as symptoms (example, fatigue, nausea, vomiting, arthralgia, myalgia, pyrexia, chills, rigors) occurring within 24 hours of E7777 infusion. 2) Capillary leak syndrome (CLS) CTCAE Grade 4 or Grade 3 (with exceptions). A CLS event was defined as the noted occurrence of at least 2 of the following: hypotension, edema, or serum albumin less than (\<) 3.0 gram per decilitre (g/dL). 3) Clinical visual impairment. 4) Any CTCAE Grade greater than or equal to (\>=) 4 adverse event (AE) that may represent an infusion reaction. 5) Any other Grade 3 or greater toxicity assessed as related to E7777 treatment and which in the opinion of a safety consultancy investigator panel, was a dose-limiting toxicity.
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Timepoint [1]
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Cycle 1 (cycle length was 21 days)
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Primary outcome [2]
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Lead-In Part: Maximum Tolerated Dose (MTD) of E7777
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Assessment method [2]
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The MTD was defined as the safe dose level established in Lead-In Part. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the Lead-In Part.
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Timepoint [2]
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Cycle 1 (cycle length was 21 days)
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Primary outcome [3]
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Main Study Part: Objective Response Rate (ORR) by Independent Review Committee (IRC) Based on Olsen 2011 Criteria
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Assessment method [3]
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ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review committee on 2 assessments at least 3 weeks apart. The tumor response was based on global response score (GRS) Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.
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Timepoint [3]
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From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months)
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Secondary outcome [1]
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Lead-In Part: Duration of Response (DOR) Per Investigator Assessment
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Assessment method [1]
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DOR per investigator assessment was defined as the time from date when criteria for response (CR or PR) was first met until the date of the first documentation of disease progression (PD) or date of death from any cause. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. PD was defined as any new lesion or unequivocally increase of previously involved sites from nadir.
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Timepoint [1]
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From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 1 year 2 months)
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Secondary outcome [2]
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Main Study Part: Duration of Response (DOR) Per Independent Review Committee
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Assessment method [2]
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DOR per independent review committee was defined as the time from the date when criteria for response (CR or PR) was first met until the date of the first documentation of PD or date of death from any cause. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. PD was defined as any new lesion or unequivocally increase of previously involved sites from nadir.
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Timepoint [2]
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From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 3 years 6 months)
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Secondary outcome [3]
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Lead-In Part: Time to Response (TTR) Per Investigator Assessment
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Assessment method [3]
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Time to response per investigator assessment was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.
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Timepoint [3]
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From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 1 year 2 months)
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Secondary outcome [4]
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Main Study Part: Time to Response (TTR) Per Independent Review Committee
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Assessment method [4]
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Time to response per independent review committee was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.
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Timepoint [4]
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From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 3 years 6 months)
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Secondary outcome [5]
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Lead-In Part and Main Study Part: ORR Per Investigator Assessment
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Assessment method [5]
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ORR per investigator assessment was defined as the percentage of participants whose BOR was CR or PR. The tumor response was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.
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Timepoint [5]
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From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months)
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Secondary outcome [6]
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Main Study Part: ORR Per IRC Based on Prince 2010 Criteria
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Assessment method [6]
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ORR was defined as the percentage of participants whose BOR was CR, clinical complete response (CCR) or PR per IRC. The tumor response was based on Prince 2010 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. CCR was defined as tumor residue not visible on esophagogram, computed tomography (CT), endoscopy, positron emission tomography (PET)-CT.
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Timepoint [6]
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From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months)
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Secondary outcome [7]
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Lead-In Part and Main Study Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [7]
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TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported.
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Timepoint [7]
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From the first dose of study drug up to 30 days after the last dose (Up to 3 years and 7 months)
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Secondary outcome [8]
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Lead-In Part: Maximum Serum Concentration (Cmax) of E7777
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Assessment method [8]
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Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no Pharmacokinetic (PK) data was collected and analyzed for these doses and cycles.
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Timepoint [8]
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Cycles 1, 3, 5 Day 1: Pre-dose up to 300 minutes post-dose (Cycle length was 21 days)
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Secondary outcome [9]
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Main Study Part: Maximum Serum Concentration (Cmax) of E7777
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Assessment method [9]
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Timepoint [9]
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Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 minutes post-dose (Cycle length was 21 days)
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Secondary outcome [10]
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Lead-In Part: Area Under the Curve From Time 0 to Time t (AUC[0-t]) of E7777
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Assessment method [10]
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Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles. Here, min\*ng/mL means minute\*nanogram per milliliter.
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Timepoint [10]
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Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours Post-dose (Cycle length was 21 days)
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Secondary outcome [11]
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Main Study Part: Area Under the Curve From Time 0 to Time t (AUC[0-t]) of E7777
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Assessment method [11]
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Timepoint [11]
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Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [12]
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Lead-In Part: Area Under the Curve From Time 0 to Time Infinity (AUC[0-inf]) of E7777
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Assessment method [12]
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Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles.
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Timepoint [12]
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Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [13]
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Main Study Part: Area Under the Curve From Time 0 to Time Infinity (AUC[0-inf]) of E7777
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Assessment method [13]
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Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint.
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Timepoint [13]
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Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [14]
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Lead-In Part: Terminal Elimination Half-life (t1/2) of E7777
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Assessment method [14]
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Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles.
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Timepoint [14]
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0
Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [15]
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Main Study Part: Terminal Elimination Half-life (t1/2) of E7777
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Assessment method [15]
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0
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Timepoint [15]
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Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [16]
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Lead-In Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax)
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Assessment method [16]
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Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles.
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Timepoint [16]
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Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [17]
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Main Study Part: Time to Reach Maximum (Peak) Concentration After Drug Administration (Tmax)
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Assessment method [17]
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Timepoint [17]
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Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [18]
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Lead-In Part: Total Body Clearance (CL) of E7777
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Assessment method [18]
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Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles. Here, mL/min/kg means milliliter per minute per kilogram.
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Timepoint [18]
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Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [19]
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Main Study Part: Total Body Clearance (CL) of E7777
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Assessment method [19]
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Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint.
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Timepoint [19]
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Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [20]
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Lead-In Part: Volume of Distribution at Steady State (Vdss) of E7777
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Assessment method [20]
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Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles.
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Timepoint [20]
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Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [21]
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Main Study Part: Volume of Distribution at Steady State (Vdss) of E7777
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Assessment method [21]
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Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint.
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Timepoint [21]
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Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
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Secondary outcome [22]
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Lead-In Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-interleukin (IL)-2 Antibodies
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Assessment method [22]
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Immunogenicity was assessed by determining the anti-E7777 and anti-IL-2 antibodies in serum using validated methods. Percentage of participants testing positive for Anti-E7777 and Anti-IL-2 antibodies were reported.
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Timepoint [22]
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
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Secondary outcome [23]
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Main Study Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies
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Assessment method [23]
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Immunogenicity was assessed by determining the anti-E7777 and anti-IL-2 antibodies in serum using validated methods. Percentage of participants testing positive for Anti-E7777 and Anti-IL-2 antibodies were reported.
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Timepoint [23]
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1
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Secondary outcome [24]
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Main Study Part: Number of Participants With Objective Skin Response
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Assessment method [24]
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Modified severity weighted assessment tool (mSWAT) was used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.
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Timepoint [24]
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Up to 30 months
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Secondary outcome [25]
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Main Study Part: Duration of Skin Response
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Assessment method [25]
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The duration of skin response based on the mSWAT score was defined as time from the date when criteria for skin response (CR or PR) was first met until the date of documented PD or death due to any cause for those participants with a confirmed PR or CR. mSWAT was used to measure skin disease severity based on the percentage of BSA with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.
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Timepoint [25]
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Up to 30 months
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Secondary outcome [26]
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Main Study Part: Time to Skin Response
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Assessment method [26]
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The time to skin response based on the mSWAT score was defined as time from the date of first dose to the date when criteria for skin response (CR or PR) were first met. mSWAT was used to measure skin disease severity based on the percentage of BSA with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.
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Timepoint [26]
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Up to 30 months
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Eligibility
Key inclusion criteria
Participants must meet all of the following criteria to be included in the study:
1. Age greater than or equal to 18 years.
2. Histopathologic diagnosis of CTCL (mycosis fungoides [MF] or Sezary Syndrome [SS]), confirmed by skin biopsy, or lymph node, or blood assessment, of current disease.
3. CD25 assay-positive tumor, defined as detectable CD25 on greater than or equal to 20% of total lymphoid infiltrate in biopsied lesions by immunohistochemistry.
4. CTCL disease stage at study entry as follows, according to ISCL/EORTC (Olsen 2011).
* Lead-In Part: Stage IA - IV, except participants with CNS involvement.
* Main Study: Stage I - III
5. History of prior therapies for CTCL: must have had prior therapy, any number of prior therapies allowed.
Topical treatments (except topical chemotherapy) and steroids are not considered as prior therapies.
6. A minimum washout period of 4 weeks after previous CTCL therapy is recommended before the first dose of E7777.
Participants must have recovered from any adverse effects from any previous CTCL therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade <2 before starting study drug. A shorter washout may be allowed if participant is experiencing progressive disease despite ongoing treatment.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 in the Lead-In Part and performance status of 0 or 1 in the Main Study.
8. Life expectancy greater than or equal to 3 months in the Lead-In Part and greater than or equal to 12 months in the Main Study.
9. Adequate bone marrow reserves as evidenced by:
* platelets greater than or equal to 100,000/mm^3 (100 x 10^9/L)
* clinically stable hemoglobin greater than or equal to 9 gram per deciliter (g/dL) (90 g/L) and hematocrit greater than or equal to 27% without transfusion support
10. Normal hepatic function as evidenced by:
* bilirubin <= 1.5* upper limit if normal (ULN) and alkaline phosphatase <=3.0*ULN
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0*ULN
* albumin >= 3.0 g/dL (30 g/L)
11. Adequate renal function as evidenced by serum creatinine less than or equal to 1.8 mg/dL (158 umol/L) or calculated creatinine clearance greater than or equal to 50 mL/min (per the Cockcroft-Gault formula) with less than 2+ protein or 24- hour urine creatinine clearance greater than or equal to 50 mL/minute with 24- hour urine protein less than 1gram.
12. Provide written informed consent prior to any study-specific screening procedures.
13. Females may not be lactating or pregnant at Screening or Baseline
14. All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically
15. Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partner must meet the criteria above
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
Participants who meet any of the following criteria will be excluded from the study:
1. Prior denileukin diftitox therapy
2. Use of topical steroids within 14 days of Day 1 of initial therapy is not allowed.Topical steroids or systemic low dose steroids of less than or equal to 10 milligram per day (mg/day) prednisone are allowed in participants with erythroderma who have been on corticosteroids for a prolonged period of time and where discontinuation may lead to rebound flare in disease. The concomitant steroid medication is allowed as long as the type of steroid, route of administration, and steroid dose remain the same as what the participant had been receiving for a prolonged period of time.
3. Active malignancy (except for CTCL, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix) within the past 24 months.
4. Serious intercurrent illness
5. Significant cardiac disease requiring ongoing treatment, including congestive heart failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled cardiac arrhythmia, unstable angina pectoris, or myocardial infarction (MI)
6. Significant pulmonary symptoms or disease
7. History of uncontrolled seizure disorder or active central nervous system disease
8. Major surgery within 2 weeks of study enrollment
9. Significant or uncontrolled infections requiring systemic anti-infective therapy
10. Known human immunodeficiency virus (HIV) infection; known active hepatitis B or hepatitis C infection
11. Females who are pregnant (positive urine test) or breastfeeding
12. Any history of a medical condition or a concomitant medical condition that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/05/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/12/2021
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Sample size
Target
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Accrual to date
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Final
112
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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0
Westmead Hospital - Westmead
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Recruitment hospital [2]
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Epworth Healthcare Freemasons - East Melbourne
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Recruitment hospital [3]
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Peter MacCallum Cancer Institute - East Melbourne
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
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Arkansas
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Country [3]
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0
United States of America
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State/province [3]
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0
California
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Country [4]
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0
United States of America
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State/province [4]
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0
Connecticut
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
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0
Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Massachusetts
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Country [9]
0
0
United States of America
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State/province [9]
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0
New Jersey
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Country [10]
0
0
United States of America
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State/province [10]
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0
New York
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Pennsylvania
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Country [12]
0
0
United States of America
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State/province [12]
0
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Texas
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Country [13]
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Puerto Rico
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State/province [13]
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0
San Juan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eisai Inc.
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Address
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Country
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Other collaborator category [1]
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0
Commercial sector/industry
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Name [1]
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Dr. Reddy's Laboratories Limited
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Address [1]
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0
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Country [1]
0
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Citius Pharmaceuticals, Inc.
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Summary
Brief summary
The purpose of this trial is to assess the efficacy of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL) in Stage I - III participants as assessed by objective response rate (ORR). A lead-in dose-finding part was used to determine dose level 9 microgram per kilogram (mcg/kg) E7777 that is being used to test efficacy and safety.
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Trial website
https://clinicaltrials.gov/study/NCT01871727
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Contacts
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/27/NCT01871727/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/27/NCT01871727/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01871727
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