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An Open-Label, Dose Escalation Phase I Trial of MK0646 Given as a One to Two Hour Every Other Week Infusion in Patients With Relapsed or Refractory Locally Advanced or Metastatic Cancers


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

An Open-Label, Dose Escalation Phase I Trial of MK0646 Given as a One to Two Hour Every Other Week Infusion in Patients With Relapsed or Refractory Locally Advanced or Metastatic Cancers


Trial Duration of Treatment : Patients will receive study drug for about 12 weeks. Patients
may be able to receive MK0646 for as long as 1 year if it seems to be stopping the growth of
their cancer and not causing bad side effects. If the patient has a complete response to
MK0646, you can have up to 8 additional weeks of treatment.


Inclusion Criteria:



Males and females with advanced solid tumors who have failed to respond to standard
therapy, ages 18 years and older, with adequate organ function

Exclusion Criteria:

- Patient is using growth hormones or growth hormone inhibitors

- Patient is known to be allergic to components of the drug or similar drugs (e.g.
monoclonal antibodies such as rituximab or biological therapies such as
immunoglobulin G

- Patient has had chemotherapy, radiotherapy, or biological therapy within 4 - 6 weeks
of entering the study or has not recovered from previous therapy

- Patient is taking part in or has taken part in a study of an investigational compound
or device within 30 days of their first dose of study drug

- Patient has an active Central Nervous System metastases and/or carcinomatous
meningitis. However, a patient who has completed a course of therapy and is clinical
stable may be able to participate

- Patient is pregnant or breastfeeding

- Patient is HIV positive

- Patient has a history of Hepatitis B or C

- Patient has symptomatic ascites or pleural effusion. However, if the patient has
received treatment and is stable, they may be able to participate

- Female patient plans to become pregnant or a male patient who plans to impregnate
their partner during the time the study is on going

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:

Blood concentrations of study drug; dose limiting toxicity (DLT)

Outcome Time Frame:

After first dose; prior to next dose of study drug

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2008_511

NCT ID:

NCT00635778

Start Date:

August 2006

Completion Date:

November 2008

Related Keywords:

  • Advanced Solid Tumors

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