Study of Individualized Amonafide to Treat Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to assess the safety and efficacy of Amonafide in men with androgen-independent prostate cancer, assigned to individualized doses of Amonafide based on acetylator phenotype information (doses adjusted on individual metabolism).

Key facts

Study ID

NCT00087854

Run by

Xanthus Pharmaceuticals, Inc.

People needed

40

Starts

2004-03-01

Expected to finish

2005-12-01

Last updated by the study team

2008-04-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men 18 years or older;
• Metastatic androgen-independent prostate cancer with evidence of progression;
• Zero or one prior course of chemotherapy for metastatic disease;
• Up to two prior courses of non-cytotoxic therapies for metastatic disease;
• Progressive measurable or assessable disease;
• Evidence of continued elevation of PSA despite antiandrogen withdrawal;
• ECOG Performance Status < 2 with an expected survival of at least 6 months;
• Adequate renal function;
• Adequate hepatic function;
• Adequate hematologic status;
• No other prior malignancy is allowed except for the following: adequately-treated basal cell or squamous cell skin cancer, adequately treated Stage I or II bladder cancer from which the subject is currently in complete remission, or any other cancer from which the subject has been disease free for 5 years;
• Subjects must have recovered from all acute toxicities from prior treatment;
• Screening visit phenotyping procedures must have been completed successfully;
• No blood transfusion within the previous 2 weeks of signature of the informed consent;
• Expected cooperation of the subject for the treatment and follow up must be obtained and documented;
• Written informed consent must be obtained and documented.

You may not qualify if…

• Clinically significant abnormal hematological parameters other than those defined in the inclusion criteria;
• Clinically significant abnormal biochemical parameters other than those defined in the inclusion criteria;
• Subjects who have been receiving bisphosphonates for less than three months prior to the first Amonafide administration;
• Known history of brain metastases;
• Subjects who are HIV positive;
• Subjects who are hepatitis B surface antigen positive or have previously documented hepatitis C infection;
• Subjects who received treatment with Growth Factors (i.e. G-CSF, GM-CSF) within 2 weeks of the signature of the informed consent form;
• Subjects who had any major surgery within four weeks of first administration of Amonafide;
• Subjects with a history of a psychological illness or condition which may interfere with the subjects ability to understand or comply with the requirements of the study;
• Subjects who received an investigational new drug within 30 days of the first dose of Amonafide;
• Any other known condition, which in the investigator's opinion would not make the subject a good candidate for the trial.

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Cancer Center at John Hopkins — Baltimore, Maryland, United States
• Barnard Cancer Center — St Louis, Missouri, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Herbert Irving Cancer Center — New York, New York, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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