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

Sun Pharma Advanced Research (SPARC)

Status and phase: Withdrawn; Phase 3

Conditions: Advanced Biliary Tract Cancer

Treatments: Drug: Reference1507; Drug: SPARC1507

Study type: Interventional

Funder types: Industry

Identifiers

NCT02597465

CLR_15_07

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

SPARC1507

Experimental group

Description:

SPARC1507

Treatment:

Drug: SPARC1507

Chemotherapy

Experimental group

Description:

Chemotherapy

Treatment:

Drug: Reference1507