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

A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00496353

Enrollment

Registered

2007-07-04

Start date

2007-06-30

Completion date

2008-11-30

Last updated

2015-03-31

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

Conditions

Neoplasm

Keywords

Neoplasm Malignant

Brief summary

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.

Interventions

DRUGMK2461

MK2461 treatment, bid, 28-day

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated.	18 Months

Secondary

Measure	Time frame
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.	18 Months

Outcome results

None listed

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