MedDataX Logo

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

NCT ID: NCT02597465

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Biliary Tract Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SPARC1507

SPARC1507

Group Type EXPERIMENTAL

SPARC1507

Intervention Type DRUG

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

Chemotherapy

Chemotherapy

Group Type EXPERIMENTAL

Reference1507

Intervention Type DRUG

Investigators choice including chemotherapy or supportive therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SPARC1507

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

Intervention Type DRUG

Reference1507

Investigators choice including chemotherapy or supportive therapy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Pharma Advanced Research Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SPARC study site

Aurora, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLR_15_07

Identifier Type: -

Identifier Source: org_study_id