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

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MK0457, VX-680 (Aurora Kinase Inhibitor)

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00099346

First Posted

December 10, 2004

Last Updated

June 16, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00099346

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Study Start Date

January 2005 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Advanced Solid Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

MK0457, VX-680 (Aurora Kinase Inhibitor)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Colorectal Cancer, Advanced Solid Tumors

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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