Clinical trial · Interventional
Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)
Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Previously Treated With Imatinib
NCT01110668CI-TRIAL-00026193completedPhase 2ClinicalTrials.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)
This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
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 Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nilotinib | Drug | Nilotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nilotinib
- interventionNames
- Drug: Nilotinib
Primary outcomes (1)
- measure
- To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
- timeFrame
- every 8 weeks
Secondary outcomes (1)
- measure
- To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg.
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic * Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose * At least one measurable site of disease on CT scan at Visit-2 * WHO Performance Status of 0, 1 or 2 at Visit-2 * Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2 Exclusion Criteria: * Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib. * Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks * Prior or concomitant malignancies other than GIST * Impaired cardiac function at Visit-1 or 2 * Patients with severe and/or uncontrolled concurrent medical disease * Use of therapeutic coumarin derivatives * Use of any medications that prolong the QT interval * Use of CYP3A4 inhibitors * Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery * Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks prior to Visit-1 or who have not recovered from side effects of such therapy Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.