An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen
Data Collection
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * at least 18 yrs of age * diagnosis of adenocarcinoma of the prostate * no detectable metastatic disease as assessed by bone and CT scans * has increasing serum PSA concentrations * life expectancy of at least 3 months * ECOG of 0 or 1 * has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period Exclusion Criteria: * has asymptomatic disease * has active GI ulceration or bleeding * has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit * bilirubin \>2x ULN or ALT or AST \>2xULN or serum creatinine \>1.5mg/dL * hemoglobin \<9g/dL or platelets below 100,000/uL or ANC below 1500/uL * receiving treatment for HIV with protease inhibitors * has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin * has used investigational drug with previous one month
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location