NCT00496353

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

July 2, 2007

Last Update Submit

March 30, 2015

Conditions

Neoplasm

Keywords

Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated.

    18 Months

Secondary Outcomes (1)

  • 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

Interventions

MK2461DRUG

MK2461 treatment, bid, 28-day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be at least 18 years of age, with adequate organ function, and an ecog performance of \<2

You may not qualify if:

  • No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation
  • Patients must not have primary central nervous system tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

5H-benzo(4,5)cyclohepta(1,2-b)pyridin-5-one

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2007

First Posted

July 4, 2007

Study Start

June 1, 2007

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

March 31, 2015

Record last verified: 2015-03