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

This study has been completed.
Sponsor:
Information provided by:
Aprea AB
ClinicalTrials.gov Identifier:
NCT00900614
First received: May 11, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Hematologic Neoplasms
Prostatic Neoplasms
 Drug: APR-246
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aprea AB:

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. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period. [ Time Frame: continuously during 21 days ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: continuously, during 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: May 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: APR-246
    Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900614

Locations
Sweden
Section of Haematology and Coagulation, Sahlgrenska University Hospital
Göteborg, Sweden, 41345
Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge
Stockholm, Sweden, SE 141 86
Department of Haematology, Akademiska Hospital
Uppsala, Sweden, 75185
Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital
Uppsala, Sweden, 75185
Urology clinic, University Hospital
Örebro, Sweden, 70185
Department of Hematology, University Hospital
Örebro, Sweden, 70185
Sponsors and Collaborators
Aprea AB
Investigators
Principal Investigator: Sören Lehmann, MD, PhD Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden
  More Information

No publications provided

Responsible Party: Charlotta Liljebris, Aprea AB
ClinicalTrials.gov Identifier: NCT00900614     History of Changes
Other Study ID Numbers: APR-246-01
Study First Received: May 11, 2009
Last Updated: June 22, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Aprea AB:
Hematologic malignancy
Prostate carcinoma
Hematologic cancer
Prostate cancer

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Hematologic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on June 13, 2013