Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction

Sponsor

Astex Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00113113

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tumors	Drug: Rubitecan	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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