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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00900614
First Posted: May 13, 2009
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aprea Therapeutics AB
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Aprea Therapeutics 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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital
Uppsala, Sweden, 75185
Department of Haematology, Akademiska Hospital
Uppsala, Sweden, 75185
Department of Hematology, University Hospital
Örebro, Sweden, 70185
Urology clinic, University Hospital
Örebro, Sweden, 70185
Sponsors and Collaborators
Aprea Therapeutics AB
Investigators
Principal Investigator: Sören Lehmann, MD, PhD Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden
  More Information

Responsible Party: Charlotta Liljebris, Aprea AB
ClinicalTrials.gov Identifier: NCT00900614     History of Changes
Other Study ID Numbers: APR-246-01
First Submitted: May 11, 2009
First Posted: May 13, 2009
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Aprea Therapeutics 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