Clinical trial · Interventional
A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 232 in Adult Subjects With Advanced Solid Tumors or Multiple Myeloma
NCT01723020CI-TRIAL-00053646completedPhase 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)
First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancy | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Oncology | — | UNRESOLVED | — |
| Oncology Patients | — | UNRESOLVED | — |
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 232 | Drug | Navtemadlin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMG 232
- description
- AMG 232 is an anti-cancer agent.
- interventionNames
- Drug: AMG 232
Primary outcomes (1)
- measure
- Safety of AMG 232
- timeFrame
- 36 months
- description
- Subject incidence of adverse events, dose limiting toxicities, and clinically significant changes in vital signs, weight, ECGs and clinical laboratory tests
Secondary outcomes (1)
- measure
- Objective Tumor Response
- 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, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma * Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma. * 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 brain metastases * For solid tumor-History or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years * Active infection requiring intravenous (IV) antibiotics * Anti-tumor therapy * Therapeutic or palliative radiation therapy within 30 days of starting treatment * Currently enrolled in another investigational device or drug study
References
Publications (0)
Data not yet available
No reference posted for this study.