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A Phase I Study of MK0646 in Combination With Cetuximab and Irinotecan in Patients With Advanced or Metastatic Colorectal Cancer


Phase 1
20 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Phase I Study of MK0646 in Combination With Cetuximab and Irinotecan in Patients With Advanced or Metastatic Colorectal Cancer


Inclusion Criteria:



- Patient Is 20 Years Of Age Or Older

- Patient Has A Histologically- Or Cytologically- Confirmed Colorectal Cancer

- Patient Has Previously Failed Both Irinotecan And Oxaliplatin Containing Regimens And
Should Have Progressed On Or Within 3 Months Of Completing Their Last Line Of Therapy
With Objective Radiological Evidence Of Progression As Verified By Previous
Radiologic Scans

- Patient Must Have Adequate Organ Function

Exclusion Criteria:

- Patient Has Had Chemotherapy, Radiotherapy, Or Biological Therapy Within 4 Weeks
Prior To Initial Dosing On This Study Or Whose Toxicities From Agents Administrated 4
Weeks Earlier Have Not Resolved To At Least Grade 1 Or Baseline

- Patient Has Experienced Intolerable Toxicity To Irinotecan Therapy

- Patient Has Prior Exposure To Igf-1r Inhibitors Or Egfr Inhibitors (E.G. Cetuximab)

- Patient Is Concurrently Using Growth Hormone (Gh), Or Growth Hormone Inhibitors

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:

Any clinical or laboratory adverse experiences

Outcome Time Frame:

42 days

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

2009_602

NCT ID:

NCT00925015

Start Date:

June 2009

Completion Date:

December 2010

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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