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
18 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
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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