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Evaluation of Patients With Bulky GIST Using Sunitinib

NCT01054911 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-09-22

Study results available
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Summary

The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs.

Conditions

  • Tumor

Interventions

DRUG

Sunitinib

All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.

PROCEDURE

Surgery

Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • James A. Posey, M.D. · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Entities

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 NCT01054911 on ClinicalTrials.gov