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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Advanced Biliary Tract Cancer
• Intervention / Treatment: Drug: SPARC1507; Drug: Reference1507

Detailed Description

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

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • SPARC study site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Pharma Advanced Research Company Limited

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: CLR_15_07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No