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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00099346
Other study ID # 0457-001
Secondary ID MK0457-0012004_0
Status Terminated
Phase Phase 1
First received December 10, 2004
Last updated June 16, 2015
Start date January 2005
Est. completion date April 2007

Study information

Verified date June 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
MK0457, VX-680 (Aurora Kinase Inhibitor)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.
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