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Sponsored by: |
Kyowa Hakko Kirin Pharma, Inc. |
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Information provided by: | Kyowa Hakko Kirin Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00838578 |
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 |
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Colorectal Cancer |
Drug: KRN330 |
Phase I Phase II |
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 |
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
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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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. |
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 |
KRN330 Colorectal Cancer |
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 |
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 |