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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00900614

Enrollment

Registered

2009-05-13

Start date

2009-05-31

Completion date

2010-10-31

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Neoplasms, Prostatic Neoplasms

Keywords

Hematologic malignancy, Prostate carcinoma, Hematologic cancer, Prostate cancer

Brief summary

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.

Interventions

DRUGAPR-246

Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	21 days

Secondary

Measure	Time frame
Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.	continuously during 21 days
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.	continuously, during 21 days

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026