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Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
This study is currently recruiting participants.
Verified by Kyowa Hakko Kirin Pharma, Inc., April 2009
First Received: February 4, 2009   Last Updated: April 29, 2009   History of Changes
Sponsored by: Kyowa Hakko Kirin Pharma, Inc.
Information provided by: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00838578
  Purpose

The primary objective of the Phase I portion of this study is to assess the safety of KRN330 in combination with irinotecan in patients with metastatic colorectal cancer.

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 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) treatment failure in patients with metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: KRN330
Phase I
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I/II Study of KRN330 Plus Irinotecan After 5-Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) Failure in Patients With Metastatic Colorectal Cancer

Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Primary Outcome Measures:
  • Phase I Portion [ Time Frame: 6 weeks post initial KRN330 treatment ] [ Designated as safety issue: Yes ]
  • Safety Assessment (incidence and severity of adverse events) [NCI CTCAE version 3.0] [ Time Frame: 6 weeks post initial KRN330 treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 102
Study Start Date: March 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
KRN330: Experimental
Open-label, dose-escalation study of KRN330 plus Irinotecan after 5-Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) Failure in Patients with Metastatic Colorectal Cancer
Drug: KRN330
Open-label, dose-escalation study of KRN330 plus Irinotecan after 5-Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) Failure in Patients with Metastatic Colorectal Cancer

  Eligibility

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

Inclusion Criteria:

  • Have histologically confirmed colorectal cancer that is metastatic with measurable disease.
  • For the Phase I portion: Have recurred or progressed after at least one FOLFOX +/- bevacizumab regimen but no more than three prior chemotherapy or biologic regimens for metastatic colorectal cancer.
  • For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line regimen for metastatic colorectal cancer.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838578

Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center, Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007-2113
Contact: Karen Voel     202-687-3821     Kd252@georgetown.edu    
Principal Investigator: John L. Marshall, M.D.            
United States, New York
NYUCI Clinical Trials Office, New York University Cancer Institute Not yet recruiting
New York, New York, United States, 10016
Contact: Denise Rodriguez     212-263-3712     denise.rodriguez@nyumc.org    
Principal Investigator: Howard S. Hochster, M.D.            
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Sharon Yin     615-936-0849     sharon.yin@vanderbilt.edu    
Principal Investigator: Jordan A. Berlin, M.D.            
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sara Ramsey     615-329-7240     Sara.Ramsey@scresearch.net    
Principal Investigator: Johanna C. Bendell, M.D.            
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Pharma, Inc ( Carolyn Huntenburg, VP )
Study ID Numbers: KRN330-US-02
Study First Received: February 4, 2009
Last Updated: April 29, 2009
ClinicalTrials.gov Identifier: NCT00838578     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
KRN330
Colorectal Cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Leucovorin
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009