Study of NK012 in Patients With Refractory Solid Tumors

Nippon Kayaku

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: NK012

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542958

N06-10089

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed malignant solid tumor for which there are no known regimens or protocol treatments of higher efficacy or priority
• Failed conventional therapy for the cancer or have a malignancy for which a conventional therapy does not exist
• Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss)
• Life expectancy of at least 12 weeks and an EOCG performance status of 0 or 1
• 18 years of age or older
• Adequate kidney, liver, and bone marrow function
• Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

• Have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse effects due to agents administered more than 4 weeks earlier
• Receiving any other investigational agent
• History of brain metastases or spinal cord compression, unless irradiated a minimum of 4 weeks before study entry and stable without requirement for corticosteroids for > 1 week
• History of allergic reactions attributed to compounds of similar chemical composition to NK012
• Concurrent serious infections (i.e., requiring an intravenous antibiotic)
• Pregnant women or women of childbearing potential who are not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline and before every NK012 administration for women of childbearing potential; no breast-feeding while on study
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements
• Significant cardiac disease
• History of serious ventricular arrhythmia
• Positive for anti-HbsAg, anti-HCV, anti-HIV, or anti-syphilis antibodies

Trial design

39 participants in 1 patient group

NK012

Experimental group

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. Dose-escalation in each patient population will proceed according to the predefined dose level. For UGT1A1\*28 (wt/wt and wt/\*28) patients, at least 3 evaluable patients will be treated at each dose level. UGT1A1 homozygous (\*28/\*28) patients will be treated at 50% of the current dose level. Patients will receive up to 6 cycles of NK012, unless they experience unacceptable toxicity or disease progression, requiring withdrawal from the study.

Treatment:

Drug: NK012