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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01006252




Trial ID
NCT01006252
Ethics application status
Date submitted
30/10/2009
Date registered
30/10/2009
Date last updated
18/06/2018

Titles & IDs
Public title
A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma
Scientific title
A Randomized Phase 3 Study of Tasisulam-sodium Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle Versus Paclitaxel as Second-line Treatment in Patients With Metastatic Melanoma
Secondary ID [1] 0 0
H8K-MC-JZAO
Secondary ID [2] 0 0
13101
Universal Trial Number (UTN)
Trial acronym
SUMMIT-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tasisulam-sodium
Treatment: Drugs - Paclitaxel

Experimental: Tasisulam-sodium - Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.

Active Comparator: Paclitaxel - Paclitaxel 80 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression


Treatment: Drugs: Tasisulam-sodium
Administered intravenously on Day 1 of a 28-day cycle, until disease progression.

Treatment: Drugs: Paclitaxel
80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - OS is duration from enrollment to death; OS censored for participants who were alive at last contact.
Timepoint [1] 0 0
Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months
Secondary outcome [1] 0 0
Progression Free Survival (PFS) - PFS is time from date of first dose to first observation of disease progression (PD); PD=20% increase in sum of the longest diameter of target lesions, or death from any cause.
Timepoint [1] 0 0
Randomization to date of objectively determined PD, or death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 13.70 months
Secondary outcome [2] 0 0
Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR) - Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions.
Timepoint [2] 0 0
First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months
Secondary outcome [3] 0 0
Duration of Response (DoR) for Participants Having an Objective Response of Partial Response (PR) or Complete Response (CR) - Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions. Analysis was adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group. Due to limited number of responses for either treatment arm, DoR analysis was not performed.
Timepoint [3] 0 0
First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months
Secondary outcome [4] 0 0
Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD) - Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria; PD=20% increase in sum of the longest diameter of target lesions.
Timepoint [4] 0 0
First date RECIST criteria met for CR, PR, or SD until first date of documented progressive disease (PD), or death from any cause (assessed every other cycle) up to 13.70 months
Secondary outcome [5] 0 0
Time to Deterioration in the Functional Assessment of Cancer Therapy-Melanoma Trial Outcome Index (FACT-M TOI) Score - FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. FACT-M TOI is the sum of FACT-M physical well-being, functional well-being, and melanoma subscales. Scores range from 0 to 120; Higher scores=better quality of life (QoL). FACT-M TOI score deterioration was defined as time from randomization to a minimally important difference in TOI score or death.
Timepoint [5] 0 0
Randomization to first date of deterioration in FACT-M TOI, or death from any cause (assessed every cycle and up to 30 days following treatment discontinuation) up to 13.21 months
Secondary outcome [6] 0 0
Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation - FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Timepoint [6] 0 0
Baseline at Cycle 2, up to 30 days following treatment discontinuation
Secondary outcome [7] 0 0
Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation - FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Timepoint [7] 0 0
Baseline at Cycle 3, up to 30 days following treatment discontinuation
Secondary outcome [8] 0 0
Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation - FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Timepoint [8] 0 0
Baseline at Cycle 4, up to 30 days following treatment discontinuation
Secondary outcome [9] 0 0
Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation - EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe the status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Timepoint [9] 0 0
Baseline at Cycle 2, up to 30 days following treatment discontinuation
Secondary outcome [10] 0 0
Change From Baseline at Cycle 3 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation - EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Timepoint [10] 0 0
Baseline at Cycle 3, up to 30 days following treatment discontinuation
Secondary outcome [11] 0 0
Change From Baseline at Cycle 4 Baseline in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation - EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Timepoint [11] 0 0
Baseline at Cycle 4, up to 30 days after treatment discontinuation
Secondary outcome [12] 0 0
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) During Cycle 1
Timepoint [12] 0 0
After drug infusion in Cycle 1 (5 samples drawn over the 28-day cycle)
Secondary outcome [13] 0 0
Pharmacokinetics: Maximum Plasma Concentration (Cmax) During Cycle 2
Timepoint [13] 0 0
After drug infusion in Cycle 2 (2 samples drawn over the 28-day cycle)

Eligibility
Key inclusion criteria
- Have a histologic and/or cytologic diagnosis of metastatic melanoma (Stage IV).

- Have the presence of evaluable disease as defined by the Response Evaluation Criteria
in Solid Tumors (RECIST 1.0).

- Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG)
Scale.

- Have progressed after 1 previous systemic treatment containing dacarbazine or
temozolomide for metastatic melanoma.

- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6
weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the
acute effects of therapy (except alopecia).

- Have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) or
greater than or equal to 30 grams per liter (g/L).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have received greater than or equal to 2 previous chemotherapy-containing systemic
treatment regimens for metastatic melanoma. An immunotherapy or antibody-based regimen
(including biologic agents and vaccination-based treatments), or treatment with a
targeted agent (for example, BRAF or c-Kit inhibitor is not counted as a prior
treatment regimen for determining study eligibility, unless either was combined with a
cytotoxic drug).

- Have active central nervous system (CNS) or leptomeningeal metastasis (brain
metastasis) at the time of study entry. Participants with signs or symptoms of
neurological compromise should have appropriate radiographic imaging performed before
study entry to rule out occult brain metastasis. Participants with a history of a
solitary CNS metastasis previously treated with curative intent (for example,
stereotactic radiation or surgery) and not requiring steroids are eligible.

- Are receiving warfarin.

- Have primary ocular or mucosal melanoma.

- Any previous treatment with paclitaxel or a paclitaxel-containing regimen for
metastatic melanoma.

- Have serious concomitant disorders, including active bacterial, fungal, or viral
infection, incompatible with the study (at the discretion of the investigator).

- Have previously completed or withdrawn from this study or any other study
investigating tasisulam-sodium.

- Have a known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor
oil).

- Are pregnant or lactating.

- Have received a recent (within 30 days before enrollment) or are receiving concurrent
yellow fever vaccination.

- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBSAg), or hepatitis C antibodies (HCAb).

- Are unable to withhold dosing of non-steroidal anti-inflammatory drugs (NSAIDs) or
proton-pump inhibitors (PPIs) for at least 72 hours before and after treatment with
tasisulam-sodium.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Coffs Harbour
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Townsville
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Woolloongabba
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nedlands
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4810 - Townsville
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study was to see how tasisulam-sodium affected metastatic
melanoma when compared against paclitaxel as measured by overall survival.
Trial website
https://clinicaltrials.gov/show/NCT01006252
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries