Clinical trial · Expanded Access
Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia
An Open-label, Multicenter, Expanded Access Study of Oral AMN107 in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase.
- 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 further evaluate if AMN107 is safe in adults with chronic myeloid leukemia who are resistant or intolerant to imatinib and to provide patients access to this new drug until the drug becomes commercially available.
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 |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMN107 | Drug | Nilotinib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Imatinib-resistant or -intolerant Philadelphia chromosome-positive chronic myeloid leukemia in blast crisis, accelerated phase, or chronic phase. * Chronic myeloid leukemia patients who have been treated with an investigational tyrosine kinase inhibitor. * Laboratory values within normal limits. Exclusion criteria: * Impaired cardiac function. * Acute or chronic liver or renal disease considered unrelated to tumor. * Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol. * Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval or to inhibit the metabolism of AMN107 (CYP3A4/5 inhibitors). * Patients with a history of another malignancy that is currently clinically significant or currently requires active intervention. Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (1)
- DERIVEDZhou L, Meng F, Yin O, Wang J, Wang Y, Wei Y, Hu P, Shen Z. Nilotinib for imatinib-resistant or -intolerant chronic myeloid leukemia in chronic phase, accelerated phase, or blast crisis: a single- and multiple-dose, open-label pharmacokinetic study in Chinese patients. Clin Ther. 2009 Jul;31(7):1568-75. doi: 10.1016/j.clinthera.2009.07.016. PMID 19695406