Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 3588 for:    colon cancer AND Colonic Diseases

Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00838578
Recruitment Status : Terminated (Per protocol, the study was terminated based on interim analysis results)
First Posted : February 6, 2009
Results First Posted : March 23, 2015
Last Update Posted : November 11, 2015
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )

Tracking Information
First Submitted Date  ICMJE February 4, 2009
First Posted Date  ICMJE February 6, 2009
Results First Submitted Date  ICMJE March 19, 2014
Results First Posted Date  ICMJE March 23, 2015
Last Update Posted Date November 11, 2015
Study Start Date  ICMJE March 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0 [ Time Frame: Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
  • Phase I Portion [ Time Frame: 6 weeks post initial KRN330 treatment ]
  • Safety Assessment (incidence and severity of adverse events) [NCI CTCAE version 3.0] [ Time Frame: 6 weeks post initial KRN330 treatment ]
Change History Complete list of historical versions of study NCT00838578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
Assess the efficacy (tumor response [RECIST]) of KRN330 plus irinotecan, obtain information on the KRN330 PK profile, and determine the degree of immunogenicity. [ Time Frame: 5 weeks after initial KRN330 treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer
Brief Summary The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorectal cancer.
Detailed Description

Phase II portion is an open-label, single arm study. Based on the results of the Phase I portion, weekly KRN330 (0.5 mg/kg) and biweekly irinotecan (180 mg/m2) will be used in the Phase II portion. To be eligible for the Phase II portion, a patient will have recurred or progressed within 6 months of the last cycle of FOLFOX/CapOx +/- bevacizumab (first-line or adjuvant regimen for metastatic colorectal cancer). Patients will continue the treatment until disease progression.

Per protocol, the decision was made to terminate the study based on interim analysis results. The Response Rate in Phase II did not meet the protocol-specified RR of 15% when 0.5 mg/kg KRN330 was administered weekly in combination with irinotecan(180 mg/m2)biweekly.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Biological: KRN330
    KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.
  • Drug: Irinotecan
    Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.
Study Arms  ICMJE Experimental: KRN330 + Irinotecan
open label, single arm
Interventions:
  • Biological: KRN330
  • Drug: Irinotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 10, 2012)
65
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2009)
102
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have histologically confirmed colorectal cancer that is metastatic with measurable disease.
  • For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin because of intolerable toxicity are also eligible.
  • At least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).
  • Have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.
  • At least 4 weeks have elapsed since any major surgery.
  • Have ECOG performance status of 0, 1, or 2.
  • Have adequate bone marrow and organ function

Exclusion Criteria:

  • Have an active, uncontrolled infection.
  • Have known HIV positive status.
  • Have known or suspected cerebral metastasis.
  • Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
  • Have a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).
  • Have a history of greater than or equal to Grade 2 allergic reaction or hypersensitivity following exposure to humanized or human monoclonal antibodies (but not chimeric antibodies).
  • Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00838578
Other Study ID Numbers  ICMJE KRN330-US-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )
Study Sponsor  ICMJE Kyowa Hakko Kirin Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Kurman, MD Kyowa Hakko Kirin Pharma, Inc.
PRS Account Kyowa Kirin Pharmaceutical Development, Inc.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP