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A Study to Determine the Activity of SCH 717454 in Subjects With Relapsed or Recurrent Colorectal Cancer (Study P04721AM1)
This study is currently recruiting participants.
Verified by Schering-Plough, December 2008
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00551213
  Purpose

The purpose of this study is to determine the activity of SCH 717454 in patients with relapsed or recurrent colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: SCH 717454
Drug: Chemotherapy and SCH 717454
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate
U.S. FDA Resources
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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Response rate by PET. [ Time Frame: Approximately 4 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess Safety and tolerability of SCH 717454. [ Time Frame: Until discontinuation of SCH 717454. ] [ Designated as safety issue: Yes ]
  • Tumor response rate, duration of response, and tumor growth rate. [ Time Frame: Until disease progression. ] [ Designated as safety issue: No ]

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
SCH 717454: Experimental
SCH 717454
Drug: SCH 717454
SCH 717454 will be administered intravenously once every two weeks until disease progression.
Chemotherapy followed by SCH 717454.: Active Comparator
Chemotherapy followed by SCH 717454
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.

Detailed Description:

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.

  Eligibility

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

Inclusion Criteria:

  • Older than 18 years of age, of any race, and gender;
  • Diagnosis of histologically confirmed relapsed or recurrent colorectal carcinoma that has progressed on at least first-line therapy;
  • Must have a CT or MRI scan performed at some point during their immediate prior treatment or observation in order to determine tumor growth rate;
  • Must have measurable disease on a CT or MRI study, performed during Screening;
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2 and a minimum life expectancy of ≥4 months;
  • Must have adequate organ function within 3 weeks prior to treatment assignment

Exclusion Criteria:

  • History of another malignancy;
  • Known treated or untreated leptomeningeal metastasis, or a metastatic central nervous system lesion;
  • Surgery within 3 weeks;
  • Radiation therapy within 6 weeks;
  • A history of uncontrolled diabetes mellitus, defined as a hemoglobin A1C of >7.5% in a patient with known diabetes mellitus;
  • A recent myocardial infarction (within the past year); or a subject who at the time of Screening presents with unstable or uncontrolled angina, New York Heart Association Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram abnormality;
  • An active infection;
  • A subject with clinically significant hepatitis at Screening, or a subject that is hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus seropositive.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551213

Contacts
Contact: SP Clinical Trial Registry Call Center 1-888-772-8734

Locations
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
Sponsors and Collaborators
Schering-Plough
Investigators
Study Director: Brian D Lu, MD, PhD Schering-Plough
  More Information

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

Keywords provided by Schering-Plough:
anti-IGF-1R

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Recurrence
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009