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Study of NK012 in Patients With Refractory Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00542958
First received: October 11, 2007
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Cancer
 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00542958

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

No publications provided

Responsible Party: Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov 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.:
Cancer
Refractory solid tumor

ClinicalTrials.gov processed this record on May 23, 2013