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
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.