Clinical trial · Interventional
Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer
An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma
NCT00900614CI-TRIAL-00039823completedPhase 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)
The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APR-246 | Drug | Eprenetapopt | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Dose-Limiting Toxicity (DLT) is reached and HFD is defined accordingly, OR the dose, which is expected to result in maximum plasma concentration close to, but not exceeding 35 μg/ml in any single patient without showing signs of DLT.
- timeFrame
- 21 days
Secondary outcomes (2)
- measure
- Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.
- timeFrame
- continuously during 21 days
- measure
- Determination of the PK profile for up to 22 hours after the last APR-246 infusion. Cmax (maximal plasma concentration), AUC (area under the curve), t1/2 (half-life) and clearance will be determined.
- timeFrame
- continuously, during 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Summary criteria for participant selection: Inclusion Criteria: * Male or female ≥ 18 years of age. * Any below mentioned advanced disease, which is not eligible for other therapies. The diagnosis should have been confirmed either histologically or cytologically: 1. Acute myeloid leukemia. 2. Acute lymphoid leukemia. 3. Chronic lymphocytic leukemia. 4. Chronic myeloid leukemia. 5. Chronic myelomonocytic leukemia. 6. Multiple myeloma. 7. Non Hodgkin's lymphoma. 8. Hodgkin's lymphoma. 9. Myelodysplastic syndrome. 10. Myelofibrosis. 11. Hormone refractory, metastatic prostate carcinoma.
References
Publications (0)
Data not yet available
No reference posted for this study.