Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00113113
First received: June 3, 2005
Last updated: January 22, 2013
Last verified: June 2005
  Purpose

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 Intervention Phase
Tumors
Drug: Rubitecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction

Resource links provided by NLM:


Further study details as provided by Astex Pharmaceuticals:

Estimated Enrollment: 54
Study Start Date: August 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113113

Locations
United States, Missouri
The Center for Cancer Care and Research
St. Louis, Missouri, United States, 63141
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Astex Pharmaceuticals
  More Information

No publications provided

Responsible Party: Astex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00113113     History of Changes
Other Study ID Numbers: RFS 2000-40, SGI-RUB-040, RFS 2000-040
Study First Received: June 3, 2005
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astex Pharmaceuticals:
rubitecan
Orathecin
9-nitrocamptothecin
solid tumors
organ dysfunction
renal dysfunction
hepatic dysfunction
RFS 2000

Additional relevant MeSH terms:
Rubitecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014