MK0457 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Colorectal Cancer and Other Advanced Solid Tumors

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00099346
First received: December 10, 2004
Last updated: January 21, 2010
Last verified: January 2010

December 10, 2004
January 21, 2010
January 2005
April 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00099346 on ClinicalTrials.gov Archive Site
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MK0457 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Colorectal Cancer and Other Advanced Solid Tumors
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

Study with an investigational drug in patients with recurrent or non-responsive colorectal cancer or other advanced solid tumors.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Advanced Solid Tumors
Drug: MK0457, VX-680 (Aurora Kinase Inhibitor)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
April 2007
April 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00099346
2004_095, MK0457-001
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Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP