MK2461 Phase I/II Study in Patients With Advanced Solid Tumors (MK-2461-002 AM1)(COMPLETED)

Merck Sharp & Dohme LLC26 enrolled

Overview

The purposes of this phase I portion are; 1) to evaluate the safety and tolerability of MK2461 and 2) to determine the recommended phase 2 dose or doses of MK2461. The purpose of the phase II portion is to evaluate the anti-tumor efficacy of MK2461.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasm

Interventions

MK2461DRUG

MK2461 treatment, bid, 28-day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must be at least 18 years of age, with adequate organ function, and an ecog performance of \<2 Exclusion Criteria: * No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation * Patients must not have primary central nervous system tumor

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated.

Time frame: 18 Months

Secondary Outcomes

To evaluate the anti-tumor efficacy of MK2461 in patients with advanced solid tumor by assessing the response rate, progression- free survival, duration of response, time to response and time to progression.

Time frame: 18 Months

Data from ClinicalTrials.gov

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