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

Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496353
• Other study ID #: 2461-002
• Secondary ID: 2007_016
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 2, 2007
• Last updated: March 30, 2015
• Start date: June 2007
• Est. completion date: November 2008

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm

Intervention

Drug:
• MK2461
MK2461 treatment, bid, 28-day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated.		18 Months	Yes
Secondary	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	No

External Links

•   (MedWatch - FDA maintained medical product safety Information)
•   (Merck: Patient & Caregiver U.S. Product Web Site)