Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-04 @ 7:41 PM
Study NCT ID:
NCT00542958
Status:
COMPLETED
Last Update Posted:
2019-10-28
First Post:
2007-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of NK012 in Patients With Refractory Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-24', 'studyFirstSubmitDate': '2007-10-11', 'studyFirstSubmitQcDate': '2007-10-11', 'lastUpdatePostDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype', 'timeFrame': 'At the end of Cycle 1 (each cycle is 21 days)'}, {'measure': 'Maximum tolerated dose of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype', 'timeFrame': 'At the end of Cycle 1 (each cycle is 21 days)'}, {'measure': 'Recommended phase II dose of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)', 'description': 'After MTD was determined, the administration schedule was changed to every 28 days per cycle, considering patient safety.'}], 'secondaryOutcomes': [{'measure': 'Toxicity profile of NK012 in all patients', 'timeFrame': 'Through study completion (6 cycles of study drug administration period and 30 days of follow-up period), an average of 5 months for 21-day cycle or 6 months for 28-days cycle.'}, {'measure': 'Antitumor activity of NK012 according to RECIST criteria in all patients', 'timeFrame': 'Through study completion (6 cycles of study drug administration period and 30 days of follow-up period), an average of 5 months for 21-day cycle or 6 months for 28-days cycle.', 'description': 'Overall response will be evaluated every 2 cycles'}, {'measure': 'Pharmacokinetic parameter: Maximum concentration (Cmax)', 'timeFrame': 'Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.'}, {'measure': 'Pharmacokinetic parameter: Time to reach the maximum concentration (Tmax)', 'timeFrame': 'Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.'}, {'measure': 'Pharmacokinetic parameter: Terminal-phase half life (T1/2z)', 'timeFrame': 'Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.'}, {'measure': 'Pharmacokinetic parameter: Area under the concentration-time curve for time zero to infinity (AUCinf)', 'timeFrame': 'Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.'}, {'measure': 'Pharmacokinetic parameter: Total body clearance (CLtot)', 'timeFrame': 'Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.'}, {'measure': 'Pharmacokinetic parameter: Volume of distribution at steady-state (Vss)', 'timeFrame': 'Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Refractory solid tumor'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether NK012 is safe and effective in the treatment of refractory solid tumors', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed malignant solid tumor for which there are no known regimens or protocol treatments of higher efficacy or priority\n* Failed conventional therapy for the cancer or have a malignancy for which a conventional therapy does not exist\n* Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss)\n* Life expectancy of at least 12 weeks and an EOCG performance status of 0 or 1\n* 18 years of age or older\n* Adequate kidney, liver, and bone marrow function\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* 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\n* Receiving any other investigational agent\n* 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\n* History of allergic reactions attributed to compounds of similar chemical composition to NK012\n* Concurrent serious infections (i.e., requiring an intravenous antibiotic)\n* 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\n* 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\n* Significant cardiac disease\n* History of serious ventricular arrhythmia\n* Positive for anti-HbsAg, anti-HCV, anti-HIV, or anti-syphilis antibodies'}, 'identificationModule': {'nctId': 'NCT00542958', 'briefTitle': 'Study of NK012 in Patients With Refractory Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nippon Kayaku Co., Ltd.'}, 'officialTitle': 'A Phase I Dose-escalation Study of NK012 Administered Intravenously as a Single Dose Every Three Weeks in Patients With Refractory Solid Tumors', 'orgStudyIdInfo': {'id': 'N06-10089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NK012', '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. Dose-escalation in each patient population will proceed according to the predefined dose level.\n\nFor UGT1A1\\*28 (wt/wt and wt/\\*28) patients, at least 3 evaluable patients will be treated at each dose level.\n\nUGT1A1 homozygous (\\*28/\\*28) patients will be treated at 50% of the current dose level.\n\nPatients will receive up to 6 cycles of NK012, unless they experience unacceptable toxicity or disease progression, requiring withdrawal from the study.', 'interventionNames': ['Drug: NK012']}], 'interventions': [{'name': 'NK012', 'type': 'DRUG', 'description': '9.0, 12.0, 16.0, 21.0, 28.0 mg/m\\^2, and to be determined. Intravenous infusion', 'armGroupLabels': ['NK012']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Howard A. Burris, III, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SCRI Development Innovations, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nippon Kayaku Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}