Clinical trial · Interventional
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
A Single-arm, Open-label, Multi-center, Phase Iv, Efficacy And Safety Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Gastrointestinal Stromal Tumor After Disease Progression On Or Intolerance To Imatinib Mesylate
NCT00793871CI-TRIAL-00019879GISTcompletedPhase 4Results 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)
To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors | Digestive System Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib Malate (SU011248) | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sunitinib
- description
- single agent sunitinib, single arm
- interventionNames
- Drug: Sunitinib Malate (SU011248)
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks)
- description
- PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven't yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a \>=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-proven diagnosis of malignant GIST (Gastrointestinal Stromal Tumors). * Evidence of unidimensionally measurable disease * Failure of prior treatment with imatinib or intolerant to imatinib * Male or female, 18 years of age or older. * ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1. * Resolution of all acute toxic effects * Adequate organ function. Exclusion Criteria: * Anticancer treatment after last dose of imatinib * Major surgery within 4 weeks or radiation therapy within 2 weeks. * Grade 3 hemorrhage within 4 weeks prior to starting the study treatment. * Diagnosis of second malignancy within the last 5 years. * History of brain disease. * Cardiac disease within 12 months. * Thyroid function abnormality. * Ongoing cardiac dysrhythmias. * Uncontrolled hypertension. * Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers. * HIV or AIDS related illness. * Pregnancy or breastfeeding.
References
Publications (0)
Data not yet available
No reference posted for this study.