A Phase I Dose-escalation Study of NK012 Administered Intravenously as a Single Dose Every Three Weeks in Patients With Refractory Solid Tumors
This is a Phase I dose-escalation study of the intravenous administration of NK012 in
patients with refractory solid tumors. Patients will receive NK012 as an intravenous
infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21
days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients
with UGT1A1*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/*28) variants as
one group, and patients with UGT1A1*28 homozygous variant (*28/*28) as another group.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity and Maximum Tolerated Dose/Recommended Phase II Dose of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype
Within 21 days of NK012 administration (Cycle 1)
Yes
Howard A. Burris, III, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Food and Drug Administration
N06-10089
NCT00542958
March 2007
December 2011
Name | Location |
---|---|
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |