Clinical trial · Interventional
A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia
NCT02016729CI-TRIAL-00037316completedPhase 1ClinicalTrials.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)
Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Advanced Malignancy | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Oncology | — | UNRESOLVED | — |
| Oncology Patients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 232 | Drug | Navtemadlin | ALIAS |
| Trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AMG 232
- description
- AMG 232 is an anti-cancer agent
- interventionNames
- Drug: AMG 232
- Drug: Trametinib
- type
- EXPERIMENTAL
- label
- AMG 232 & Trametinib
- description
- AMG 232 and Trametinib are anti cancer agents
- interventionNames
- Drug: Trametinib
Primary outcomes (3)
- measure
- To evaluate the safety and tolerability of AMG 232
- timeFrame
- 36 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men or women \> 18 years old * Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy * Ability to take oral medications and willing to record daily adherance to investigational product * Adequate hematological, renal, hepatic, and coagulation laboratory assessments Exclusion Criteria: * Active infection requiring intravenous (IV) antibiotics * Prior participation in an investigational study (procedure or device) within 21 days of study day 1 * Major surgery within 28 days of study day 1 * Anti-tumor therapy within 14 days of study day 1
References
Publications (1)
- DERIVEDErba HP, Becker PS, Shami PJ, Grunwald MR, Flesher DL, Zhu M, Rasmussen E, Henary HA, Anderson AA, Wang ES. Phase 1b study of the MDM2 inhibitor AMG 232 with or without trametinib in relapsed/refractory acute myeloid leukemia. Blood Adv. 2019 Jul 9;3(13):1939-1949. doi: 10.1182/bloodadvances.2019030916. PMID 31253596