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A Phase I Dose Escalation Study of MK2461 in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

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Trial Information

A Phase I Dose Escalation Study of MK2461 in Patients With Advanced Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of MK2461

Outcome Time Frame:

18 Months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2006_530

NCT ID:

NCT00518739

Start Date:

February 2007

Completion Date:

December 2008

Related Keywords:

  • Advanced Cancer
  • Neoplasms

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