Spots Global Cancer Trial Database for Study of NK012 in Patients With Refractory Solid Tumors

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Trial Identification

Brief Title: Study of NK012 in Patients With Refractory Solid Tumors

Official Title: A Phase I Dose-escalation Study of NK012 Administered Intravenously as a Single Dose Every Three Weeks in Patients With Refractory Solid Tumors

Study ID: NCT00542958

Conditions

Cancer

Interventions

NK012

Study Description

Brief Summary: The purpose of this study is to determine whether NK012 is safe and effective in the treatment of refractory solid tumors

Detailed Description: 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.