Status:
COMPLETED
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction
Lead Sponsor:
Astex Pharmaceuticals, Inc.
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00113113
Start Date
August 1 2001
Last Update
August 2 2024
Active Locations (2)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
The Center for Cancer Care and Research
St Louis, Missouri, United States, 63141