Brief Title
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
Official Title
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 in Subjects With Cancer
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1
Secondary Outcome
Overall survival in subjects treated with SPARC1507 versus Investigators choice
Condition
Advanced Biliary Tract Cancer
Intervention
SPARC1507
Study Arms / Comparison Groups
SPARC1507
Description: SPARC1507
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
December 1, 2018
Completion Date
December 1, 2019
Primary Completion Date
March 1, 2019
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02597465
Organization ID
CLR_15_07
Responsible Party
Sponsor
Study Sponsor
Sun Pharma Advanced Research Company Limited
Study Sponsor
, ,
Verification Date
December 2020