Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction

This study has been completed.

Sponsor:

Information provided by:

Astex Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00113113

First received: June 3, 2005

Last updated: October 12, 2009

Last verified: June 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	June 3, 2005
Last Updated Date	October 12, 2009
Start Date ^ICMJE	August 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00113113 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction
Official Title ^ICMJE	Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Tumors
Intervention ^ICMJE	Drug: Rubitecan
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	54
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00113113
Other Study ID Numbers ^ICMJE	RFS 2000-40, SGI-RUB-040, RFS 2000-040
Has Data Monitoring Committee
Responsible Party	David S Smith, Vice President - Regulatory & Quality Assurance, SuperGen, Inc.
Study Sponsor ^ICMJE	Astex Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Astex Pharmaceuticals
Verification Date	June 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top