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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00551213 |
The purpose of this study is to determine the activity of SCH 717454 in patients with relapsed or recurrent colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: SCH 717454 Drug: Chemotherapy and SCH 717454 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Fixed-Sequence, Open-Label Study to Determine the Activity of SCH 717454 as Assessed by Positron Emission Tomography in Subjects With Relapsed or Recurrent Colorectal Cancer |
Estimated Enrollment: | 59 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SCH 717454: Experimental
SCH 717454
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Drug: SCH 717454
SCH 717454 will be administered intravenously once every two weeks until disease progression.
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Chemotherapy followed by SCH 717454.: Active Comparator
Chemotherapy followed by SCH 717454
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Drug: Chemotherapy and SCH 717454
One cycle of chemotherapy currently approved and available on the market for use in colorectal cancer followed by SCH 717454.
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It will be a randomized, fixed-sequence, open-label study in patients with diagnosis of relapsed or recurrent colorectal cancer to assess response, duration of response, safety and tolerability of SCH 717454.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
United States, California | |
Investigational Site 6 | Recruiting |
Los Angeles, California, United States, 90033 | |
Investigational Site 12 | Recruiting |
Palm Springs, California, United States, 92262 | |
United States, Florida | |
Investigational Site 8 | Recruiting |
Jacksonville, Florida, United States, 32256 | |
United States, Georgia | |
Investigational Site 1 | Recruiting |
Atlanta, Georgia, United States, 30341 | |
United States, Illinois | |
Investigational Site 3 | Recruiting |
Chicago, Illinois, United States, 60637 | |
Investigational Site 13 | Recruiting |
Peoria, Illinois, United States, 61615 | |
United States, Washington | |
Investigational Site 7 | Recruiting |
Seattle, Washington, United States, 98109 | |
Canada | |
Investigational Site 5 | Recruiting |
London, Canada, N6A 4L6 | |
Investigational Site 11 | Recruiting |
Montreal, Canada, H2L 4M1 | |
Investigational Site 9 | Recruiting |
Toronto, Canada, M5G 2M9 | |
Investigational Site 10 | Recruiting |
Montreal, Canada, H3A 1A1 |
Study Director: | Brian D Lu, MD, PhD | Schering-Plough |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04721 |
Study First Received: | October 29, 2007 |
Last Updated: | December 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00551213 |
Health Authority: | United States: Food and Drug Administration |
anti-IGF-1R |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Recurrence Colorectal Neoplasms |
Neoplasms Neoplasms by Site |