New hope for Drug-Resistant stomach cancer? sorafenib trial underway
NCT ID NCT00265798
First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This phase 2 trial tests the drug sorafenib in 38 patients with gastrointestinal stromal tumor (GIST) that has worsened despite treatment with imatinib and sunitinib. Sorafenib works by blocking enzymes that help tumors grow and by cutting off blood supply to the cancer. The study measures how many patients see their tumors shrink and how long the disease stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sorafenib (Nexavar)
- What this could lead to
- If it works, sorafenib could offer a new treatment option for patients with GIST that no longer responds to standard therapies.
- What could go wrong
- This is a small, early-phase trial (38 participants) and may not lead to a widely available treatment. The drug may cause side effects and may not shrink tumors in all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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38 people
The number who actually took part.
- Started
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Sep 2005
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed gastrointestinal stromal tumor * Not amenable to curative surgery * Kit-expressing tumor * Disease progression (i.e., new lesion or 20% increase in unidimensional tumor size) on or after treatment with imatinib mesylate and sunitinib malate * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques OR \> 10 mm by spiral CT scan * Only site of measurable disease must be outside of previously irradiated area * No known brain metastases * Performance status - ECOG 0-2 * More than 3 months * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Bilirubin normal * AST and ALT \< 2.5 times upper limit of normal * Creatinine ≤ 1.5 mg/dL * Creatinine clearance \> 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No uncontrolled hypertension * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * No evidence of bowel perforation or obstruction * No prior angiogenesis inhibitors * No immunotherapy after the last dose of imatinib mesylate or sunitinib malate * No chemotherapy or chemoembolization therapy after the last dose of imatinib mesylate or sunitinib malate * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * At least 14 days since prior imatinib mesylate or sunitinib malate * No prior sorafenib * No prior inhibitors of MAPK-signaling intermediates * No other investigational agent after the last dose of imatinib mesylate or sunitinib malate * Concurrent anticoagulation therapy with warfarin allowed provided the following criteria are met: * On a therapeutic stable warfarin dose * INR ≤3 * No active bleeding or pathologic condition that confers a high risk of bleeding * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent administration of any of the following: * Enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) * Hypericum perforatum (St. John's wort) * Rifampin * No other concurrent anticancer agents or therapies
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Central Illinois Hematology Oncology Center
Springfield, Illinois, 62702, United States
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
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Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
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Other studies related to the condition(s) this trial covers.
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