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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: Phase 3
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Advanced Biliary Tract Cancer
• Biliary Tract Neoplasms

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