Clinical trial · Interventional
Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction
A Phase I Study of DX-8951f (Exatecan Mesylate for Injection) in Patients With Renal Dysfunction
NCT00045318CI-TRIAL-00011268completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of exatecan mesylate in treating patients who have advanced solid tumors and kidney dysfunction.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exatecan mesylate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced solid tumor refractory to standard therapy or for which no standard therapy exists * Renal function as defined by the following parameters: * Normal (creatinine clearance (CrCl) greater than 80 mL/min) * Mild dysfunction (CrCl 50-80 mL/min) * Moderate dysfunction (CrCl 30-50 mL/min) * Severe dysfunction (CrCl less than 30 mL/min) * End-stage renal disease (requiring dialysis) * No symptomatic or active brain metastases (e.g., edema or progression on CT scan or MRI) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 g/dL Hepatic * Bilirubin normal * AST or ALT no greater than 2 times upper limit of normal * Albumin at least 2.8 g/dL Renal * See Disease Characteristics Cardiovascular * No active congestive heart failure * No uncontrolled angina * No myocardial infarction within the past 6 months Other * No concurrent serious infection * No other life-threatening illness * No overt psychosis or mental disability or other incompetency that would preclude informed consent * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biologic therapy Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered * No prior exatecan mesylate * No other concurrent anticancer chemotherapy Endocrine therapy * No concurrent anticancer hormonal therapy * Concurrent megestrol for appetite stimulation allowed Radiotherapy * At least 4 weeks since prior radiotherapy and recovered * No concurrent anticancer radiotherapy Surgery * At least 4 weeks since prior major surgery and recovered * No concurrent anticancer surgery Other * At least 4 weeks since prior investigational drugs including analgesics or antiemetics * At least 1 week since prior grapefruit juice * No other concurrent anticancer therapy * No other investigational drugs during and for 4 weeks after study * No concurrent grapefruit juice * No other concurrent anticancer cytotoxic therapy * Concurrent chronic hemodialysis or ambulatory peritoneal dialysis allowed
References
Publications (0)
Data not yet available
No reference posted for this study.