Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer
An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma
1 other identifier
interventional
36
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2009
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 11, 2009
CompletedFirst Posted
Study publicly available on registry
May 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJuly 31, 2019
July 1, 2019
1.4 years
May 11, 2009
July 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
21 days
Secondary Outcomes (2)
Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.
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.
continuously, during 21 days
Interventions
Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.
Eligibility Criteria
You may qualify if:
- 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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Section of Haematology and Coagulation, Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
Department of Hematology, University Hospital
Örebro, 70185, Sweden
Urology clinic, University Hospital
Örebro, 70185, Sweden
Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge
Stockholm, SE 141 86, Sweden
Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital
Uppsala, 75185, Sweden
Department of Haematology, Akademiska Hospital
Uppsala, 75185, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sören Lehmann, MD, PhD
Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2009
First Posted
May 13, 2009
Study Start
May 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
July 31, 2019
Record last verified: 2019-07