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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900614
• Other study ID #: APR-246-01
• Status: Completed
• Phase: Phase 1
• Start date: May 2009
• Est. completion date: October 2010

Study information

• Verified date: July 2019
• Source: Aprea Therapeutics AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Neoplasms
• Prostatic Neoplasms

Intervention

Drug:
• APR-246
Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.

Locations

Country	Name	City	State
Sweden	Section of Haematology and Coagulation, Sahlgrenska University Hospital	Göteborg
Sweden	Department of Hematology, University Hospital	Örebro
Sweden	Urology clinic, University Hospital	Örebro
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

Sponsors (1)

Lead Sponsor	Collaborator
Aprea Therapeutics AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.		continuously during 21 days
Secondary	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