Sorafenib for Imatinib/Sunitinib-failed GIST

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-08-31

Brief Summary

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With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor imatinib, there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after imatinib and sunitinib. In preclinical models, sorafenib inhibits KIT activity and cell growth of imatinib-resistant tumors. The objective of this multi-center, non-randomized phase II study is to evaluate the safety and activity of sorafenib given as third-line therapy for GIST.

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Detailed Description

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This is a non-randomized, open-label, multi-center, phase II study recruiting patients with advanced GIST who are pretreated with both imatinib and sunitinib. The current study will provide an estimate of the activity and safety of sorafenib in GIST. The primary study endpoint is the disease control rate (DCR), defined as complete or partial response or stable disease of at least 24 weeks of sorafenib therapy. Secondary endpoints include PFS, OS and safety.

Patients with advanced (unresectable and/or metastatic) GIST who failed after previous therapy involving both imatinib and sunitinib will be eligible. Failure to imatinib and sunitinib is defined as disease progression regardless of intervening response during therapy, or intolerance. There is no limit to the number of prior therapies a patient may have received (e.g., patients may have received therapy with nilotinib, other TKIs, or chemotherapy in addition to imatinib or sunitinib).

Conditions

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Gastrointestinal Stromal Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sorafenib

The patients will receive daily oral administration of sorafenib 400 mg twice daily.

Group Type EXPERIMENTAL

Sorafenib

Intervention Type DRUG

The patients will receive daily oral administration of sorafenib 400 mg twice daily.

Interventions

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Sorafenib

The patients will receive daily oral administration of sorafenib 400 mg twice daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age over 18 years
* advanced GIST
* failed (progressed and/or intolerable) after prior treatments for GIST
* ECOG performance status of 0\~2
* resolution of all toxic effects of prior treatments
* no prior radiotherapy within 1 month before registration
* measurable lesion as defined by RECIST
* adequate marrow, hepatic, renal and cardiac functions
* provision of a signed written informed consent

Exclusion Criteria

* severe co-morbid illness and/or active infections
* pregnant or lactating women
* history of other malignancies
* active CNS disease not controllable with radiotherapy or corticosteroids
* active and uncontrollable bleeding from gastrointestinal tract
* prior history of sorafenib use
* gastrointestinal obstruction or malabsorption syndrome

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No