Know Cancer

or
forgot password

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer


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

Thank you

Trial Information

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer


Inclusion Criteria:



- Patients 18 years or older

- Must agree to consume high fat meal and agree to fasting conditions

- Limit alcohol consumption

Exclusion Criteria:

- Patient has a history of drug or alcohol abuse within 5 years of start of study

- Patient is known to have HIV

- Patient has participated in another investigational study within 4 weeks of start of
study

- Patient cannot stop taking certain medications or herbal remedies

- Patient will require immunologic, radiation, surgery, or chemotherapy during the
study

- Patient requires frequent blood transfusions

- Female patient is pregnant or nursing

- Patient has an active Hepatitis B or C infection

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:

Safety, tolerability, and PK of MK0683

Outcome Time Frame:

28 Days

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2008_544

NCT ID:

NCT00750178

Start Date:

November 2004

Completion Date:

November 2005

Related Keywords:

  • Cancer, Advanced

Name

Location