MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: MK2461

Study type: Interventional

Funder types: Industry

Identifiers

NCT00518739

2006_530

2461-001

Details and patient eligibility

About

This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be at least 18 years of age, with adequate organ function, and an ECOG performance of <2
• Patients must be willing to undergo pre-study and post dose tumor biopsy and have tumor accessible to biopsy (waived during Part A)

Exclusion criteria

• No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation
• Patients must not have primary central nervous system tumor
• Patient has had prescription or non-prescription drugs or other products known to be metabolized by CYP3A4 that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)