Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer

Aprea Therapeutics

Status and phase: Completed; Phase 1

Conditions: Hematologic Neoplasms; Prostatic Neoplasms

Treatments: Drug: APR-246

Study type: Interventional

Funder types: Industry

Identifiers

NCT00900614

APR-246-01

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)