Study of Individualized Amonafide to Treat Prostate Cancer

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xanthus Pharmaceuticals, Inc.
• Treatments: Amonafide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.