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Completed

NCT Number: NCT00113113

Study of Rubitecan in Cancer Patients With Renal or Hepatic 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.

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Key information

Conditions

Tumors Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Liver Diseases Male Urogenital Diseases Neoplasms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Center for Cancer Care and Research, St Louis, Missouri, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rubitecan

Drug

Sponsors and collaborators

Lead sponsor

Astex Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2001
First posted
Jun 6, 2005
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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