Trial | NCT00900614  Report issue

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 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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.
Study Started
May 31
2009
Primary Completion
Oct 31
2010
Study Completion
Oct 31
2010
Last Update
Jul 31
2019

Drug APR-246

Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.

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:

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.
No Results Posted