Clinical trial · Interventional
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
NCT00068380CI-TRIAL-00033706completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Stage IV Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (imatinib mesylate)
- description
- Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: imatinib mesylate
- Other: laboratory biomarker analysis
Primary outcomes (6)
- measure
- Response Rate
- timeFrame
- Up to 6 years
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by X-Ray, MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- measure
- Toxicity Summary
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with metastatic and/or unresectable carcinoma of the stomach, who have measurable disease * Life expectancy \> 3 months * Karnofsky Performance Status \> 60% * Absence of an active infection * Granulocyte count of \> 1,500/mm\^3 * Hemoglobin (Hgb) \>= 9 mg/dl * Serum bilirubin =\< 1.5 mg/dl, regardless of liver involvement secondary to tumor * Platelets \> 100,000/mm\^3 * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) \< 2.5 x the institutional upper limit of normal * Calculated creatinine clearance of \> 60 ml/min * Patients must have signed written informed consent * Female patients of child-bearing potential must have a negative blood or urine pregnancy test within two weeks prior to initial study treatment * Patients who have had prior chemotherapy or radiation therapy must have recovered from any toxicities prior to study entry * Patients must have radiographic imaging to document measurable disease within 28 days prior to initial study therapy Exclusion Criteria: * Diagnosis of resectable carcinoma of the stomach * Major surgery within four weeks of study entry * Brain metastasis or known seizure disorder * Fertile men and women not using an acceptable method of contraception * Pregnant or lactating patients are excluded since STI571 may be harmful to the developing fetus and child * Patients known to be HIV positive and receiving HAART are excluded because of possibly pharmacological interactions * Active peptic ulceration or active gastrointestinal bleeding or any active bleeding disorders * Use of therapeutic doses of coumadin (warfarin) as anticoagulation * Medical, social, or psychological factors which would prevent the patient from completing the treatment protocol * Patients with serious intercurrent illness which would preclude tolerance and completion of the protocol treatment
References
Publications (0)
Data not yet available
No reference posted for this study.