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

Sponsor

Aprea Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00900614

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Neoplasms Prostatic Neoplasms	Drug: APR-246	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Acute myeloid leukemia.
Acute lymphoid leukemia.
Chronic lymphocytic leukemia.
Chronic myeloid leukemia.
Chronic myelomonocytic leukemia.
Multiple myeloma.
Non Hodgkin's lymphoma.
Hodgkin's lymphoma.
Myelodysplastic syndrome.
Myelofibrosis.
Hormone refractory, metastatic prostate carcinoma.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Section of Haematology and Coagulation, Sahlgrenska University Hospital	Göteborg	Sweden	41345
2	Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge	Stockholm	Sweden	SE 141 86
3	Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital	Uppsala	Sweden	75185
4	Department of Haematology, Akademiska Hospital	Uppsala	Sweden	75185
5	Department of Hematology, University Hospital	Örebro	Sweden	70185
6	Urology clinic, University Hospital	Örebro	Sweden	70185

Sponsors and Collaborators

Aprea Therapeutics

Investigators

Principal Investigator: Sören Lehmann, MD, PhD, Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden