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 : July 31, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hematologic Neoplasms Prostatic Neoplasms | Drug: APR-246 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
- Drug: APR-246
Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.
- 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 ]
- 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 ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Summary criteria for participant selection:
Inclusion Criteria:
- Male or female ≥ 18 years of age.
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Any below mentioned advanced disease, which is not eligible for other therapies. The diagnosis should have been confirmed either histologically or cytologically:
- Acute myeloid leukemia.
- Acute lymphoid leukemia.
- Chronic lymphocytic leukemia.
- Chronic myeloid leukemia.
- Chronic myelomonocytic leukemia.
- Multiple myeloma.
- Non Hodgkin's lymphoma.
- Hodgkin's lymphoma.
- Myelodysplastic syndrome.
- Myelofibrosis.
- Hormone refractory, metastatic prostate carcinoma.
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
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 |
Principal Investigator: | Sören Lehmann, MD, PhD | Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden |
Responsible Party: | Aprea Therapeutics |
ClinicalTrials.gov Identifier: | NCT00900614 |
Other Study ID Numbers: |
APR-246-01 |
First Posted: | May 13, 2009 Key Record Dates |
Last Update Posted: | July 31, 2019 |
Last Verified: | July 2019 |
Hematologic malignancy Prostate carcinoma Hematologic cancer Prostate cancer |
Neoplasms Prostatic Neoplasms Hematologic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Hematologic Diseases |