A Randomized, Open-Label, Comparative, Parallel-Group, Mu... | NCT02597465

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

NCT02597465

Sponsor

Sun Pharma Advanced Research Company Limited

Status

Withdrawn

Last Update Posted

Dec 14, 2020Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Advanced Biliary Tract Cancer

Interventions

SPARC1507
Reference1507

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decided not to initiate the study for alternate commercial strategy

Expanded Access Info

Start Date

Dec 1, 2018Estimated

Primary Completion Date

Mar 1, 2019Estimated

Completion Date

Dec 1, 2019Estimated

First Submitted Date

Nov 3, 2015

First Submission Date that Met QC Criteria

Nov 3, 2015

First Posted Date

Nov 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2020

Last Update Posted Date

Dec 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SPARC1507	Experimental	SPARC1507	Drug: SPARC1507
Chemotherapy	Experimental	Chemotherapy	Drug: Reference1507

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPARC1507	Drug	The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle	SPARC1507

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SPARC study site		Aurora	Colorado	80045	United States