MK2461 Phase I/II Study in Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00496353

Purpose

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.

Condition	Intervention	Phase
Neoplasm	Drug: MK2461	Phase I Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors

Further study details as provided by Merck:

Primary Outcome Measures:

To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated. [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2007
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

MK2461 treatment, bid, 28-day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496353

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

(MedWatch - FDA maintained medical product safety Information) This link exits the ClinicalTrials.gov site

(PhRMA Clinical Study Results Database - web-based repository for clinical study results) This link exits the ClinicalTrials.gov site

(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_016, MK2461-002
Study First Received:	July 2, 2007
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00496353
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck:

Neoplasm Malignant

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009