Back to resultsA Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
Primary Purpose
Advanced Biliary Tract Cancer
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SPARC1507
Reference1507
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Biliary Tract Cancer
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
Sites / Locations
- SPARC study site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SPARC1507
Chemotherapy
Arm Description
SPARC1507
Chemotherapy
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1
Secondary Outcome Measures
Overall survival in subjects treated with SPARC1507 versus Investigators choice
Overall response rate in subjects treated with PICN versus Investigators choice
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
NCT ID
NCT02597465
First Posted
November 3, 2015
Last Updated
December 10, 2020
Sponsor
Sun Pharma Advanced Research Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT02597465
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decided not to initiate the study for alternate commercial strategy
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Biliary Tract Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPARC1507
Arm Type
Experimental
Arm Description
SPARC1507
Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
SPARC1507
Intervention Description
The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle
Intervention Type
Drug
Intervention Name(s)
Reference1507
Intervention Description
Investigators choice including chemotherapy or supportive therapy
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1
Time Frame
3 years and 6 months
Secondary Outcome Measure Information:
Title
Overall survival in subjects treated with SPARC1507 versus Investigators choice
Time Frame
3 years and 6 months
Title
Overall response rate in subjects treated with PICN versus Investigators choice
Time Frame
3 years and 6 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
3 years and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
SPARC study site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
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