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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00496353
First Posted: July 4, 2007
Last Update Posted: March 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

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 ]

Enrollment: 26
Study Start Date: June 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496353


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00496353     History of Changes
Other Study ID Numbers: 2461-002
2007_016
First Submitted: July 2, 2007
First Posted: July 4, 2007
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Neoplasm Malignant