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Phase I Study Evaluating MK6592 in Combination With Docetaxel in Adult Patients With Relapsed or Refractory Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

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Trial Information

Phase I Study Evaluating MK6592 in Combination With Docetaxel in Adult Patients With Relapsed or Refractory Advanced Solid Tumors


Inclusion Criteria:



- Patients with advanced solid tumors (metastatic or local) unresponsive to standard
therapy, progressed on standard therapy, or no standard therapy exists. No limit to
the number of prior treatment regimens

- Patients may be fully active without physical restrictions, ambulatory with
restrictions on strenuous physical activity, or ambulatory and capable of self-care
but not work activities (i.e., Eastern Cooperative Oncology Group performance status
of greater than or equal to 2)

- Demonstrates adequate organ function (liver, kidneys, hematologic)

Exclusion Criteria:

- Chemotherapy or radiation therapy within 2 weeks of dosing; or unresolved side
effects(s) from prior treatment regimen

- Participation in an investigational study within 14 days of dosing

- Primary central nervous system tumor

- Active brain or spinal cord metastases. Patients who completed a course of therapy
for CNS metastases may be eligible if considered clinically stable for 3 months prior
to study entry

- Symptoms from fluid in the abdomen or around the lungs

- Requires certain drugs or other products known to be metabolized by the liver enzyme
CYP3A4

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability of MK6592 alone and in combination with docetaxel

Outcome Time Frame:

6 Months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2006_508

NCT ID:

NCT00359671

Start Date:

March 2007

Completion Date:

July 2007

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

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