An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma
18 Years
N/A
Both
Hematologic Neoplasms, Prostatic Neoplasms
Trial Information
An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
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.
Outcome Time Frame:
21 days
Safety Issue:
Yes
Principal Investigator
Sören Lehmann, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden
Authority:
Sweden: Medical Products Agency
Study ID:
APR-246-01
NCT ID:
NCT00900614
Start Date:
May 2009
Completion Date:
October 2010
Related Keywords:
- Hematologic Neoplasms
- Prostatic Neoplasms
- Hematologic malignancy
- Prostate carcinoma
- Hematologic cancer
- Prostate cancer
- Neoplasms
- Prostatic Neoplasms
- Hematologic Neoplasms
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