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NCT02597465 Clinical Trial

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

Advanced Biliary Tract Cancer Clinical Trial

Official title:
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 in Subjects With Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02597465
Other study ID # CLR_15_07
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date December 1, 2018
Est. completion date December 1, 2019

Study information
Verified date December 2020
Source Sun Pharma Advanced Research Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Subjects with advanced Biliary tract carcinoma meeting the eligibility criteria will be randomized in this study.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• SPARC1507
The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle
• Reference1507
Investigators choice including chemotherapy or supportive therapy

Locations
Country Name City State
United States SPARC study site Aurora Colorado

Sponsors (1)
Lead Sponsor Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Overall survival in subjects treated with SPARC1507 versus Investigators choice 3 years and 6 months
Secondary Overall response rate in subjects treated with PICN versus Investigators choice 3 years and 6 months
Secondary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 3 years and 6 months
See also
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Completed NCT04217954 - HAIC With Oxaliplatin, 5-FU and Bevacizumab Plus Intravenous Toripalimab for Advanced BTC Phase 2
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