MK0457 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Colorectal Cancer and Other Advanced Solid Tumors (0457-001)

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00099346

Enrollment

Unknown

Registered

2004-12-13

Start date

2005-01-31

Completion date

2007-04-30

Last updated

2015-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors, Colorectal Cancer

Brief 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).

Interventions

DRUGMK0457, VX-680 (Aurora Kinase Inhibitor)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026