Status:
COMPLETED
Study of Individualized Amonafide to Treat Prostate Cancer
Lead Sponsor:
Xanthus Pharmaceuticals, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 phenotyp...
Detailed Description
This is an open-label, Phase I/II, multicenter study of Amonafide in subjects with androgen-independent metastatic prostate cancer. Amonafide is metabolized by N-acetylation to an active metabolite, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00087854
Start Date
March 1 2004
End Date
December 1 2005
Last Update
April 23 2008
Active Locations (8)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Cancer Center at John Hopkins
Baltimore, Maryland, United States, 21231
3
Barnard Cancer Center
St Louis, Missouri, United States, 63110
4
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901