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

NCT ID: NCT00359671

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-07-31

Brief Summary

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

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Arm 1: study drug

Group Type EXPERIMENTAL

MK6592

Intervention Type DRUG

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

2

Arm 2: study drug + comparator

Group Type OTHER

MK6592

Intervention Type DRUG

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

Intervention Type DRUG

docetaxel, delivered as a standard IV infusion.

Interventions

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MK6592

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

Intervention Type DRUG

comparator: docetaxel

docetaxel, delivered as a standard IV infusion.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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United States

Other Identifiers

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MK6592-001

Identifier Type: -

Identifier Source: secondary_id

2006_508

Identifier Type: -

Identifier Source: secondary_id

6592-001

Identifier Type: -

Identifier Source: org_study_id