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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate by PET.

Outcome Time Frame:

Approximately 4 weeks.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

P04721

NCT ID:

NCT00551213

Start Date:

November 2007

Completion Date:

June 2009

Related Keywords:

  • Colorectal Cancer
  • anti-IGF-1R
  • Colorectal Neoplasms

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