Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer

Phase 1

Completed

• Conditions: Hematologic Neoplasms; Prostatic Neoplasms

• Registration Number: NCT00900614
• Lead Sponsor: Aprea Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Section of Haematology and Coagulation, Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge; 🇸🇪 Stockholm, Sweden

Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital; 🇸🇪 Uppsala, Sweden

Department of Haematology, Akademiska Hospital; 🇸🇪 Uppsala, Sweden

Department of Hematology, University Hospital; 🇸🇪 Örebro, Sweden

Urology clinic, University Hospital; 🇸🇪 Örebro, Sweden