Study of NK012 in Patients With Refractory Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
Nippon Kayaku Co.,Ltd. Identifier:
First received: October 11, 2007
Last updated: March 18, 2013
Last verified: March 2013

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

Condition Intervention Phase
Drug: NK012
Phase 1

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

Resource links provided by NLM:

Further study details as provided by Nippon Kayaku Co.,Ltd.:

Primary Outcome Measures:
  • Dose-limiting toxicity and Maximum Tolerated Dose/Recommended Phase II Dose of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype [ Time Frame: Within 21 days of NK012 administration (Cycle 1) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity profile of NK012 in all patients [ Time Frame: Minimum of 30 days after the last dose of study drug and followed for any unresolved adverse events ] [ Designated as safety issue: No ]
  • Antitumor activity of NK012 according to RECIST criteria in all patients [ Time Frame: Measured every 6 weeks (i.e., every 2 cycles) while receiving study drug ] [ Designated as safety issue: No ]
  • Limited pharmacokinetics of NK012 [ Time Frame: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: March 2007
Study Completion Date: December 2011
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: NK012
Dose escalation starting at 9 mg/m2 in UGT1A1*28 (wt/wt and wt/*28) genotype patients, IV (in the vein) over 30 minutes on Day 1 of each 21-day cycle. Number of Cycles: Up to 6 cycles, until unacceptable toxicity or disease progression develops: patients may continue treatment beyond 6 cycles if the Investigator determines that additional treatment would provide further benefit for the patient, as long as toxicity remains acceptable.

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00542958

United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Nippon Kayaku Co.,Ltd.
Principal Investigator: Howard A. Burris, III, MD SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: Nippon Kayaku Co.,Ltd. Identifier: NCT00542958     History of Changes
Other Study ID Numbers: N06-10089
Study First Received: October 11, 2007
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Nippon Kayaku Co.,Ltd.:
Refractory solid tumor processed this record on April 17, 2014