Study of NK012 in Patients With Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00542958
Recruitment Status : Completed
First Posted : October 12, 2007
Last Update Posted : March 20, 2013
Information provided by (Responsible Party):
Nippon Kayaku Co.,Ltd.

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

Condition or disease Intervention/treatment Phase
Cancer Drug: NK012 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : December 2011

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Limited pharmacokinetics of NK012 [ Time Frame: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Nippon Kayaku Co.,Ltd. Identifier: NCT00542958     History of Changes
Other Study ID Numbers: N06-10089
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Nippon Kayaku Co.,Ltd.:
Refractory solid tumor