Study Evaluating the Safety and Tolerability of L-377202 (NCT00987753) | Clinical Trial Compass
CompletedPhase 1/2
Study Evaluating the Safety and Tolerability of L-377202
United States13 participantsStarted 1999-03
Plain-language summary
The primary purpose of this study is to (1) determine the maximally tolerated dose (MTD) of L-377202 administered once every 3 weeks, (2) evaluate the safety and tolerability of L-377202 including the dose-limiting adverse effects of treatment with L-377202, and (3) assess the pharmacokinetics of various doses of L-377202 and the plasma profile of liberated doxorubicin and leu-doxorubicin.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is at least an 18-year-old male and has histologically documented, progressive carcinoma of the prostate which is refractory to hormonal manipulation. Progressive disease may be documented by new lesions on bone scan, increase in radiologically measurable disease, or an increase in PSA (at least 50% increase from nadir confirmed twice and measured at least 2 weeks apart.)
* An appropriate interval of time has passed since alteration of any hormonal therapy (e.g., 4 weeks for steroids, LHRH agonists, flutamide or megestrol acetate and 6 weeks for nilutamide and bicalutamide).
* Patient has a serum PSA of 20 ng/mL or higher.
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Patients has a life expectancy of \>3 months.
* Patient understands and agrees to participate in the study by providing written informed consent.
Exclusion Criteria:
* Patient is mentally or legally incapacitated at the time of the study or has a history (less than 5 years prior to entry) of drug or alcohol abuse or is currently a user (including "recreational use") of any illicit drugs.
* Patient has known HIV or a known HIV-related malignancy.
* Patient has participated in another study (including FDA approved drugs for a non-FDA approved indication) of an investigational agent within the last 4 weeks.
* Patient requires treatment or is anticipated to require treatment with Cyclosporine, Phenobarbital, phenytoin, or streptozocin.
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What they're measuring
1
Evaluation of the administration of L-377202 every three weeks in patients with hormone refractory prostate cancer
Timeframe: Every 3 weeks until disease progression or unacceptable toxicity