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

Phase 1
18 Years
Not Enrolling

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Trial Information

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity and Maximum Tolerated Dose/Recommended Phase II Dose of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype

Outcome Time Frame:

Within 21 days of NK012 administration (Cycle 1)

Safety Issue:


Principal Investigator

Howard A. Burris, III, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

December 2011

Related Keywords:

  • Cancer
  • Cancer
  • Refractory solid tumor



Sarah Cannon Research Institute Nashville, Tennessee  37203