Title
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
Phase
Phase 1Lead Sponsor
Aprea Therapeutics ABStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Hematologic Neoplasms Prostatic NeoplasmsIntervention/Treatment
Eprenetapopt ...Study Participants
36The 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.
Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.
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: 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.