Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction

Astex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Tumors

Treatments: Drug: Rubitecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113113

RFS 2000-40

RFS 2000-040

SGI-RUB-040

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)