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An Open-label, Dose Escalation Phase I/II Trial of a KSP Inhibitor Given as a Constant 24-Hour Infusion in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

An Open-label, Dose Escalation Phase I/II Trial of a KSP Inhibitor Given as a Constant 24-Hour Infusion in Patients With Advanced Solid Tumors


Inclusion Criteria:



- Patients who are at least 18 years of age with recurrent or non-responsive solid
tumors, or cancers for whom standard therapy does not exist. Part of the study
includes only patients who have taxane-resistant cancers.

Exclusion Criteria:

- Patients who have had treatment with any investigational therapy 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 pains, or had a
heart attack within the past 3 months, or have undergone bone marrow or stem cell
transplantation.

- Patient is pregnant or nursing.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability of MK0731 administered as a 24-hour CIV Infusion. Dose limiting toxicities. Maximum tolerated dose and recommended Phase II dose of L-001154704 administered as a 24 hour CIV infusion.

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2005_004

NCT ID:

NCT00104364

Start Date:

May 2005

Completion Date:

January 2008

Related Keywords:

  • Cancer

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