Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APR-246 | Drug | Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sören Lehmann, MD, PhD | Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Section of Haematology and Coagulation, Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden | |||
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533410 | eprenetapopt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| continuously, during 21 days |
| 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 |
| D005834 |
| Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |