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

Sponsor

Sun Pharma Advanced Research Company Limited (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02597465

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Biliary Tract Cancer	Drug: SPARC1507 Drug: Reference1507	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPARC1507 SPARC1507	Drug: SPARC1507 The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle
Experimental: Chemotherapy Chemotherapy	Drug: Reference1507 Investigators choice including chemotherapy or supportive therapy

Arm

Intervention/Treatment

Experimental: SPARC1507

SPARC1507

Drug: SPARC1507

The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle

Experimental: Chemotherapy

Chemotherapy

Drug: Reference1507

Investigators choice including chemotherapy or supportive therapy

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [3 years and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SPARC study site	Aurora	Colorado	United States	80045

Sponsors and Collaborators

Sun Pharma Advanced Research Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sun Pharma Advanced Research Company Limited

ClinicalTrials.gov Identifier:

NCT02597465

Other Study ID Numbers:

CLR_15_07

First Posted:

Nov 5, 2015

Last Update Posted:

Dec 14, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Biliary Tract Neoplasms

Study Results

No Results Posted as of Dec 14, 2020