Home
Clinical Trials
SARC021C: A Continuation Stud...

SARC021C: A Continuation Study of TH-CR-406/SARC021

Last Updated: 2016-10-13

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

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

SARC021C is a nonrandomized, open-label, multicenter, continuation study designed to provide access to TH-302 for patients currently receiving and benefiting from single agent TH-302 therapy as part of the Phase III TH-CR-406/SARC021 study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

NCT01440088

Soft Tissue Sarcoma

COMPLETED PHASE3

A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers

NCT01436565

Solid Tumor Cancers

COMPLETED PHASE1

Dose-Escalation Study of TH-302 in Combination With Doxorubicin to Treat Patients With Advanced Soft Tissue Sarcoma

NCT00742963

Soft Tissue Sarcoma

COMPLETED PHASE1/PHASE2

Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

NCT00669019

Recurrent Melanoma Stage IIA Melanoma Stage IIB Melanoma +2 more

COMPLETED PHASE2

SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas

NCT00005862

Gastrointestinal Stromal Tumor Sarcoma

COMPLETED PHASE2

Detailed Description

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

The goal of this study is to provide continuation therapy with TH-302 to patients with soft tissue sarcomas who obtained response or stabilization of disease with prior treatment on TH-CR-406/SARC021 protocol. After written informed consent has been obtained and eligibility has been established, patients will receive the study drug as part of the continuation study. Patients will receive treatment on study as long as they have clinical benefit and do not experience unacceptable toxicity.

Conditions

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

Soft Tissue Sarcoma

Interventions

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

Th-302

300 mg/m2 IV on Days 1 and 8 of a 21-day cycle.

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee.
* Previously enrolled on the TH-CR-406/SARC021 protocol and benefiting from treatment.
* Study investigator deems continued participation is appropriate based on overall health of the patient.

Exclusion Criteria

* Any of the criteria for study discontinuation are met.
* Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
* Unwillingness or inability to comply with the study protocol for any reason.

Eligible Sex

ALL

Accepts Healthy Volunteers