Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction
Phase 1
Completed
- Conditions
- Tumors
- Registration Number
- NCT00113113
- Lead Sponsor
- Astex Pharmaceuticals, Inc.
- Brief Summary
Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of rubitecan in this patient population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- The patient is at least 18 years of age.
- The patient has histologically or cytologically proven malignancy recurrent or refractory to standard treatment or for which there is no standard therapy.
- The patient has measurable disease.
- The patient has sufficiently recovered from the acute toxic effects of previous chemotherapy, radiotherapy (no less than 3 weeks prior to randomization), and/or immunotherapy.
- The patient's estimated life expectancy is at least 8 weeks.
- The patient has a National Cancer Institute Common Toxicity Criteria (NCI CTC) Performance Status between 0 and 2.
- The patient has adequate bone marrow function.
- The patient must not have active central nervous system (CNS) metastases.
Exclusion Criteria
- The patient has any serious, uncontrolled intercurrent illness or infection.
- The patient is receiving anti-retroviral therapy (HAART) for HIV infection.
- The patient is pregnant or nursing.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
The Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States