Study of NK012 in Patients With Refractory Solid Tumors
This study has been completed.
Information provided by (Responsible Party):
Nippon Kayaku Co.,Ltd.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I Dose-escalation Study of NK012 Administered Intravenously as a Single Dose Every Three Weeks in Patients With Refractory Solid Tumors
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2008 (Final data collection date for primary outcome measure)
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.
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:
|Accepts Healthy Volunteers:
- 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
- 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542958
|Sarah Cannon Research Institute
|Nashville, Tennessee, United States, 37203 |
Nippon Kayaku Co.,Ltd.
||Howard A. Burris, III, MD
||SCRI Development Innovations, LLC
No publications provided
||Nippon Kayaku Co.,Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 11, 2007
||March 18, 2013
||United States: Food and Drug Administration
Keywords provided by Nippon Kayaku Co.,Ltd.:
ClinicalTrials.gov processed this record on August 28, 2014
Refractory solid tumor