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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hematologic Neoplasms Prostatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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APR-246

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No