Advanced Biliary Tract Cancer
Conditions
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.
Interventions
DRUGSPARC1507
The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle
DRUGReference1507
Investigators choice including chemotherapy or supportive therapy
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed