Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction

Tumors Clinical Trial

Official title:

Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113113
• Other study ID #: RFS 2000-40
• Secondary ID: SGI-RUB-040RFS 2
• Status: Completed
• Phase: Phase 1
• First received: June 3, 2005
• Last updated: January 22, 2013
• Start date: August 2001

Study information

• Verified date: June 2005
• Source: Astex Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• Rubitecan

Locations

Country	Name	City	State
United States	The Center for Cancer Care and Research	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Astex Pharmaceuticals

Country where clinical trial is conducted

United States,