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

Phase 3WithdrawnNCT02597465

Sun Pharma Advanced Research Company Limited

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Advanced Biliary Tract Cancer

Interventions

SPARC1507DRUG

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

Reference1507DRUG

Investigators choice including chemotherapy or supportive therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

SPARC study site

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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 Outcomes

Overall survival in subjects treated with SPARC1507 versus Investigators choice

Time frame: 3 years and 6 months

Overall response rate in subjects treated with PICN versus Investigators choice

Time frame: 3 years and 6 months

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame: 3 years and 6 months

Data from ClinicalTrials.gov

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