Clinical trial · Interventional
Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST)
- 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 is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.
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 Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMN107, STI571 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMN107 + STI571
- interventionNames
- Drug: AMN107, STI571
Primary outcomes (1)
- measure
- To determine the MTD which will be the Phase II dose of AMN107 when given in combination with Imatinib. The MTD is defined to be the highest dose of AMN107 in combination with Imatinib given for at least 21 days in the first treatment cycle
- timeFrame
- From day 1 cycle 1 until at least six subjects have been treated at the recommended dose level and observed for at least 21 days
- description
- MTD is defined to be the highest dose of AMN in combination with imatinib given for at least 21 days in the first treatment cycle
Secondary outcomes (2)
- measure
- To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with gastrointestinal stromal tumor (GIST). * Patients who have had disease progression during imatinib therapy with 800 mg. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Patients with prior or concomitant malignancies other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ. * A history of impaired cardiac function or uncontrolled cardiovascular disease. * Severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107. * Currently taking certain medications that could affect an electrocardiogram result. * Women who are pregnant or breast feeding. * Patients unwilling or unable to comply with the protocol. NOTE: Additional inclusion and/ or exclusion criteria may apply.
References
Publications (0)
Data not yet available