Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00496353
First received: July 2, 2007
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ]

Enrollment: 26
Study Start Date: July 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MK2461
    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

Additional Information:
(MedWatch - FDA maintained medical product safety Information)  This link exits the ClinicalTrials.gov site
(Merck: Patient & Caregiver U.S. Product Web Site)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00496353     History of Changes
Other Study ID Numbers: 2007_016, MK2461-002
Study First Received: July 2, 2007
Last Updated: March 14, 2013
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 May 16, 2013