Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate

Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate

Gastrointestinal Stromal Tumor

Ongoing, but not recruiting

2

Start Date 09/01/2005

Age of Trial (yrs) 19.6

Gleevec-resistant

KIT/PDGFRA inhibitor+ VEGF inhibitor (TKI) + RAF inhibitor

Block KIT + Block KIT Signal Path

Specifically GIST and only GIST

CDR000045354, UCCRC-13780A, NCI-7028

University of Chicago, NCI

Clinical Trials Office - University of Chicago Cancer Research

773-834-7424

Oral

Note: University of Chicago maintains a central contact point for this trial.
Contact: University of Chicago Clinical Trials Office, 773-834-7424

Official Title: A Phase II Study of BAY 43-9006 for Imatinib- and Sunitinib-Resistant Malignant Gastrointestinal Stromal Tumor

Sorafenib (Nexavar / Bay 43-9006) is an oral tyrosine kinase inhibitor. It is FDA approved for kidney and liver cancer but not for GIST. This is phase II trial to see if sorafenib has activity in Gleevec and Sutent resistant GIST.
Sorafenib inhibits KIT, BRAF, mutant BRAF (including the V600E mutation), VEGFR 1,2,3, CRAF and PDGFRB. It is manufactured by Bayer and Onyx.

Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
* Objective response rate (partial and complete response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
* Overall survival [ Designated as safety issue: No ]
* Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: September 2005
Estimated Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:
Primary
* Determine the objective response rate (partial and complete response) in patients with imatinib mesylate- and sunitinib malate-resistant malignant gastrointestinal stromal tumor treated with sorafenib.
Secondary
* Determine the toxicity of this drug in these patients.
* Determine the progression-free survival and overall survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with imatinib mesylate and sunitinib malate (imatinib mesylate- and sunitinib malate-responsive disease vs primary imatinib mesylate- and sunitinib malate-refractory disease).

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.