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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
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
Post Date   08/01/2011
Protocol Number   11-06-236/West
Status   Recruiting
Current Trial Type   Interventional
Adult Clinical Trial   No
Pediatric Clinical Trial   No