NCT00496353CompletedPhase 1
A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 26
- Primary Endpoint
- To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.(18 Months)
Investigators
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