Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction

January 22, 2013 updated by: Astex Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St. Louis, Missouri, United States, 63141
        • The Center for Cancer Care and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astex Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Registration Dates

First Submitted

June 3, 2005

First Submitted That Met QC Criteria

June 3, 2005

First Posted (ESTIMATE)

June 6, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFS 2000-40
  • SGI-RUB-040
  • RFS 2000-040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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