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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01846611




Registration number
NCT01846611
Ethics application status
Date submitted
1/05/2013
Date registered
3/05/2013
Date last updated
1/04/2019

Titles & IDs
Public title
A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Scientific title
A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Secondary ID [1] 0 0
ET743OVC3006
Secondary ID [2] 0 0
CR100983
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasms 0 0
Peritoneal Neoplasms 0 0
Fallopian Tube Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trabectedin
Treatment: Drugs - DOXIL
Treatment: Drugs - Dexamethasone
Treatment: Drugs - DOXIL

Experimental: Arm A: trabectedin + DOXIL - Participants will receive DOXIL 30 millgram per meter square (mg/m^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m^2 administered as an IV infusion over approximately 3hours, every 3 weeks. Participants will be pretreated with 20 mg dexamethasone IV (or the IV equivalent) approximately 30 minutes before DOXIL study drug. As of Amendment 6, treatment with trabectedin will be discontinued for participants on treatment with trabectedin and no new participants will receive trabectedin. Participants who, in the opinion of the investigator, are deriving clinical benefit may continue treatment with single-agent DOXIL as per the local standard of care.

Active Comparator: Arm B: DOXIL - Participants will receive DOXIL, 50 mg/m^2 administered as an IV infusion over approximately 90 minutes every 4 weeks.


Treatment: Drugs: Trabectedin
1.1 mg/m^2 administered intravenously over approximately 3 hours on Day 1 of each 21-day treatment cycle.

Treatment: Drugs: DOXIL
30 mg/m^2 administered intravenously over approximately 90 minutes on Day 1 of each 21-day treatment cycle.

Treatment: Drugs: Dexamethasone
20 mg administered intravenously on Day 1 of each 21-day treatment cycle approximately 30 minutes prior to study drug infusion.

Treatment: Drugs: DOXIL
50 mg/m^2 administered intravenously over approximately 90 minutes on Day 1 of each 28-day treatment cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 4.3 years
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to 4.3 years
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 4.3 years

Eligibility
Key inclusion criteria
- Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or
fallopian tube cancer

- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

- Received first-line treatment with a platinum-based regimen and had no evidence of
disease progression for >= 6 months after the last dose

- Received second-line treatment with a platinum-based regimen, with progression of
disease after attaining a response

- Progression of disease based on imaging after the second-line platinum-based regimen
(individuals treated with a pegylated liposomal doxorubicin-containing regimen as a
second-line therapy are eligible if subsequent disease progression occurs >=9 months
from the first dose)

- Evidence of measurable disease at screening as evaluated by Response Evaluation
Criteria in Solid Tumors (RECIST) (Version 1.1)

- Participants no longer need to be able to receive intravenous (IV) dexamethasone or an
equivalent IV corticosteroid

- Have a known BRCA 1/2 mutation status (for participants who do not have a known BRCA
1/2 status at screening, a blood sample will be collected to determine the status with
the results available prior to randomization

- Laboratory values within protocol -defined parameters

- Have left ventricular ejection fraction by multigated acquisition scan (MUGA) scan or
2D-ECHO within normal limits for the institution

- Have side effects (except alopecia) of prior treatment resolved to at least Grade 1
according to the National Cancer Institute - Common Terminology Criteria of Adverse
Events (NCICTCAE) (Version 4.0)

- Have a negative urine or serum pregnancy test at screening

- Agrees to protocol-defined use of effective contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of ovarian carcinoma with mucinous histology

- Had more than 2 prior lines of systemic therapy. Maintenance therapies and hormonal
therapies are not considered additional lines of therapy

- Participants who had a prior exposure to trabectedin or hypersensitivity to any of the
excipients will not be excluded from receiving single-agent Doxil

- Prior treatment with doxorubicin or other anthracycline at cumulative doses greater
than 300 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mg
Doxil/Caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)

- Participants unwilling or unable to have a central venous catheter placed will not be
excluded from receiving single-agent Doxil

- Pregnant or breast-feeding

- Would receive study treatment within 3 weeks from radiation therapy, experimental
therapy, hormonal therapy, prior chemotherapy, or biological therapy; use an invasive
investigational device; or is currently enrolled in an investigational study

- History of another invasive malignancy (except non-metastatic basal cell carcinoma or
squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated)
unless in remission for >=5 years, or a non - invasive malignancy requiring ongoing
therapy

- Known allergies, hypersensitivity, or intolerance to Doxil, dexamethasone, or their
excipients

- Known history of central nervous system metastasis

- Known significant chronic liver disease, such as cirrhosis or active hepatitis
(potential participants who test positive for hepatitis B surface antigen or hepatitis
C antibodies are allowed provided they do not have active disease requiring antiviral
therapy)

- Had a myocardial infarct within 6 months before enrollment, New York Heart Association
(NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, clinically significant pericardial disease, or
electrocardiographic evidence of acute ischemic or active conduction system
abnormalities

- Has any of the following medical conditions: uncontrolled diabetes, psychiatric
disorder (including dementia) that prevents compliance with protocol, uncontrolled
seizures, newly diagnosed deep vein thrombosis, active systemic infection that is
likely to interfere with study procedure or results

- Has any condition that, in the opinion of the investigator, would compromise the
well-being of the participant or the study or prevent the participant from meeting or
performing study requirements

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/11/2018
Sample size
Target
Accrual to date
Final
581
Recruitment in Australia
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- Woodville
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country
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Commercial sector/Industry
Name [1] 0 0
PharmaMar
Address [1] 0 0
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Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a
third-line chemotherapy regimen (treatment) in patients with platinum-sensitive
advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who
received 2 previous lines of platinum-based chemotherapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01846611
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Address 0 0
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Contact person for scientific queries