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Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST)

NCT01323400 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-02-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST) resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.

Conditions

Interventions

DRUG

Pazopanib

Pazopanib is administered orally at 800 mg/day (one dose every morning). A dose modification is possible in case of documented toxicity, according to specific algorithms.

OTHER

Best supportive care

Best supportive care according to the investigator's judgment (chemotherapy, immunotherapy, hormone therapy are not allowed). Non-targeted radiation therapy is tolerated, as antalgic strategy. Surgery is tolerated in case of emergency.

Sponsors & Collaborators

Principal Investigators

  • Jean-Yves BLAY, MD · Centre Léon Bérard, LYON, FRANCE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-04-30
Completion
2016-02-29

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01323400 on ClinicalTrials.gov