A Phase I/IIa Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Efficacy of MK0457 Administered as a 5-Day Continuous Infusion in Patients With Advanced Colorectal Cancer and Other Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Advanced Solid Tumors
Both
Colorectal Cancer, Advanced Solid Tumors
Trial Information
A Phase I/IIa Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Efficacy of MK0457 Administered as a 5-Day Continuous Infusion in Patients With Advanced Colorectal Cancer and Other Solid Tumors
Inclusion Criteria:
- In Part I, patients who are at least 18 years of age with advanced solid tumors and
colorectal cancer will be eligible for the first part of this study. Patient must
have recovered from and be at least 3 weeks from previous cancer treatment.
- In Part II, only patients with colorectal cancer will be eligible to participate. The
patients may have received up to 3 prior treatments for their colorectal cancer.
Patients must have recovered from and be at least 3 weeks from previous therapy.
Exclusion Criteria:
- Patients who have had treatment with any investigational drug within the past 30
days.
- Patients who have certain types of blood cancers such as leukemia or lymphoma.
- Patients who have uncontrolled congestive heart failure (CHF), chest pain, or heart
attack within the past 3 months.
- Patient is pregnant or nursing.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2004_095
NCT ID:
NCT00099346
Start Date:
January 2005
Completion Date:
April 2007
Related Keywords:
- Colorectal Cancer
- Advanced Solid Tumors
- Colorectal Neoplasms
- Neoplasms
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