Text Size

MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00518739
First received: August 17, 2007
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.


Condition Intervention Phase
Advanced Cancer
 Drug: MK2461
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of MK2461 in Patients With Advanced Cancer

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 [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the Recommend Phase II Dose or doses (RP2D) based on safety, tumor pharmacodynamics, and parmacokinetics. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: February 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MK2461
    Patients will be administered oral MK2461 twice daily and will be treated for 28 day cycles. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of MK2461. 60 mg dry filled capsules, escalating to 240 mg ( for dosing in Cohort 4 & beyond).
  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
  • Patients must be willing to undergo pre-study and post dose tumor biopsy and have tumor accessible to biopsy (waived during Part A)

Exclusion Criteria:

  • No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation
  • Patients must not have primary central nervous system tumor
  • Patient has had prescription or non-prescription drugs or other products known to be metabolized by CYP3A4 that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518739

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00518739     History of Changes
Other Study ID Numbers: 2006_530, MK2461-001
Study First Received: August 17, 2007
Last Updated: April 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013