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

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ClinicalTrials.gov Identifier: NCT00900614
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Aprea Therapeutics AB

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


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


Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

Responsible Party: Charlotta Liljebris, Aprea AB
ClinicalTrials.gov Identifier: NCT00900614     History of Changes
Other Study ID Numbers: APR-246-01
First Posted: May 13, 2009    Key Record Dates
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