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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00359671

Enrollment

Registered

2006-08-02

Start date

2006-12-31

Completion date

2007-07-31

Last updated

2016-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Brief summary

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

Interventions

DRUGcomparator: docetaxel

docetaxel, delivered as a standard IV infusion.

DRUGMK6592

MK6592 delivered as a 48-hour CIV as monotherapy in Cycle 1; 48-hour CIV of MK6592 in Cycle 2 and subsequent cycles.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of MK6592 alone and in combination with docetaxel	6 Months

Secondary

Measure	Time frame
Observance of objective tumor responses in patients treated with MK6592 combined with docetaxel	6 Months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026