search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KRN330
Irinotecan
Sponsored by
Kyowa Hakko Kirin Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring KRN330, Colorectal Cancer, Antimetabolites, Antimetabolites, Antineoplastic, Digestive System Neoplasms, Immunologic Factors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Gastrointestinal Diseases, Physiological Effects of Drugs, Colonic Diseases, Irinotecan, Enzyme Inhibitors, Intestinal Diseases, Immunosuppressive Agents, Rectal Diseases, Pharmacologic Actions, Intestinal Neoplasms, Neoplasms by Site, Digestive System Diseases, Therapeutic Uses, Fluorouracil, Neoplasms, Gastrointestinal Neoplasms, Antineoplastic Agents, Phytogenic, Colorectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clearview Cancer Institute
  • Arizona Clinical Research Center
  • USC/Norris Comprehensive Cancer Center
  • Lombardi Comprehensive Cancer Center, Georgetown University Hospital
  • Florida Cancer Specialists
  • University of Florida COllege of Medicine/Shands Cancer Center
  • University of Miami - Sylvester Comprehensive Cancer Center
  • Emory University - Winship Cancer Institute
  • Greater Baltimore Medical Center
  • NYU Clinical Trials Office, New York University Cancer Institute
  • Sarah Cannon Research Institute
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KRN330 + Irinotecan

Arm Description

open label, single arm

Outcomes

Primary Outcome Measures

Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0

Secondary Outcome Measures

Full Information

First Posted
February 4, 2009
Last Updated
November 5, 2015
Sponsor
Kyowa Hakko Kirin Pharma, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00838578
Brief Title
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
Official Title
Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Per protocol, the study was terminated based on interim analysis results
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Hakko Kirin Pharma, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
KRN330, Colorectal Cancer, Antimetabolites, Antimetabolites, Antineoplastic, Digestive System Neoplasms, Immunologic Factors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Gastrointestinal Diseases, Physiological Effects of Drugs, Colonic Diseases, Irinotecan, Enzyme Inhibitors, Intestinal Diseases, Immunosuppressive Agents, Rectal Diseases, Pharmacologic Actions, Intestinal Neoplasms, Neoplasms by Site, Digestive System Diseases, Therapeutic Uses, Fluorouracil, Neoplasms, Gastrointestinal Neoplasms, Antineoplastic Agents, Phytogenic, Colorectal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KRN330 + Irinotecan
Arm Type
Experimental
Arm Description
open label, single arm
Intervention Type
Biological
Intervention Name(s)
KRN330
Intervention Description
KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kurman, MD
Organizational Affiliation
Kyowa Hakko Kirin Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clearview Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center, Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2113
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
University of Florida COllege of Medicine/Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami - Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University - Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
NYU Clinical Trials Office, New York University Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs