A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
Phase 3
Withdrawn
- Conditions
- Advanced Biliary Tract Cancer
- Interventions
- Drug: Reference1507
- Registration Number
- NCT02597465
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
An open label study to determine the efficacy and safety of SPARC1507
- Detailed Description
Subjects with advanced Biliary tract carcinoma meeting the eligibility criteria will be randomized in this study.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Evidence of advanced/metastatic biliary tract cancer
- Male or female ≥ 18 years old
- Participants must have measurable disease according to RECIST
- ECOG performance status ≤ 1
Exclusion Criteria
- Known hypersensitivity to trial treatments, or their excipients
- Prior history of treatment with any taxane therapy
- Cardiovascular disorders as per Investigator's discretion
- The subject has received radiation therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPARC1507 SPARC1507 SPARC1507 Chemotherapy Reference1507 Chemotherapy
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1 3 years and 6 months
- Secondary Outcome Measures
Name Time Method Overall survival in subjects treated with SPARC1507 versus Investigators choice 3 years and 6 months Overall response rate in subjects treated with PICN versus Investigators choice 3 years and 6 months Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 3 years and 6 months
Trial Locations
- Locations (1)
SPARC study site
🇺🇸Aurora, Colorado, United States