Treatment With MK6592 and an Anti-cancer Drug in Patients With Advanced Solid Tumors (6592-001)

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00359671
• Other study ID #: 6592-001
• Secondary ID: MK6592-0012006_5
• Status: Terminated
• Phase: Phase 1
• First received: August 1, 2006
• Last updated: November 28, 2016
• Start date: December 2006
• Est. completion date: July 2007

Study information

• Verified date: November 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A study to evaluate safety and tolerability of MK6592 in combination with an anti-cancer drug in adult patients with advanced solid tumors.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• MK6592
MK6592 delivered as a 48-hour CIV as monotherapy in Cycle 1; 48-hour CIV of MK6592 in Cycle 2 and subsequent cycles.
• comparator: docetaxel
docetaxel, delivered as a standard IV infusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of MK6592 alone and in combination with docetaxel		6 Months	Yes
Secondary	Observance of objective tumor responses in patients treated with MK6592 combined with docetaxel		6 Months	No