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| Title | An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN™ in Subjects With Cancer Who Also Have Impaired Renal Function |
|---|---|
| Disease/Condition | Phase 1¸ Organ Dysfunction¸ and Other Experimental |
| Description | This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle. |
| Eligibility Criteria | To be eligible for this study, patients must meet several criteria, including but not limited to the following: * Patient must be 18 Years and older * Subject must have histologically or cytologically confirmed advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy). * Renal function must fall into one of the following categories: * Normal function - creatinine clearance more than or equal to 80 mL/min. * Moderate impairment - creatinine clearance more than 30 to 50 mL/min. * Severe impairment - creatinine clearance 15 to less than 30 mL/min. * Adequate liver function |
| Principal Investigator | Sanjay Goel, MD |
| Phone | (718) 904-2488 |
| Contact Email | sgoel@montefiore.org |
| Post Date | 08/01/2011 |
| Protocol Number | 11-06-236/West |
| Status | Recruiting |
| Current Trial Type | Interventional |
