A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507

• Status: Withdrawn
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

An open label study to determine the efficacy and safety of SPARC1507

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

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