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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
ClinicalTrials.gov Identifier:
NCT00099346
First received: December 10, 2004
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  Purpose

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).


Condition Intervention Phase
Colorectal Cancer
Advanced Solid Tumors
 Drug: MK0457, VX-680 (Aurora Kinase Inhibitor)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Study Start Date: January 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099346

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00099346     History of Changes
Other Study ID Numbers: 2004_095, MK0457-001
Study First Received: December 10, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013