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New hope for Drug-Resistant stomach cancer? sorafenib trial underway

NCT ID NCT00265798

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

38 people

The number who actually took part.

Started

Sep 2005

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 62702, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.