Clinical trial · Interventional
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction
Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction
NCT00113113CI-TRIAL-00079417completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rubitecan | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.