A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
NCT02597465 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2020-12-14
Summary
An open label study to determine the efficacy and safety of SPARC1507
Conditions
- Advanced Biliary Tract Cancer
Interventions
- DRUG
-
SPARC1507
The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle
- DRUG
-
Reference1507
Investigators choice including chemotherapy or supportive therapy
Sponsors & Collaborators
-
Sun Pharma Advanced Research Company Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-01
- Primary Completion
- 2019-03-01
- Completion
- 2019-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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