Phase I Study of Dalotuzumab (MK0646) in Combination With Cetuximab and Irinotecan in Colorectal Cancer Patients (0646-016)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00925015
First received: June 17, 2009
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

The purposes of this study are to assess the safety, tolerability, pharmacokinetic interactions and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab and irinotecan in patients with advanced or metastatic colorectal cancer in Japan.


Condition Intervention Phase
Colorectal Cancer
Drug: dalotuzumab (MK0646)
Drug: Comparator: cetuximab
Drug: Comparator: irinotecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of MK0646 in Combination With Cetuximab and Irinotecan in Patients With Advanced or Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Any clinical or laboratory adverse experiences [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic drug-drug interactions [ Time Frame: 42 Days ] [ Designated as safety issue: No ]
  • Human Anti-Human Antibody [ Time Frame: Until the 12 weeks after the last administration of MK0646 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dalotuzumab administered on Day 22 and 36
Drug: dalotuzumab (MK0646)
Arm 1: Dalotuzumab (10 mg/kg) intravenously administered on Day 22 and 36 Arm 2: Dalotuzumab (initial infusion 15 mg/kg, subsequent infusions 7.5 mg/kg) intravenous administered on Day 8, 22 and 36 Arm 3: Dalotuzumab (10 mg/kg) intravenously administered on Day 1, 22 and 29
Other Names:
  • dalotuzumab
  • MK0646
Drug: Comparator: cetuximab
cetuximab (initial intravenous infusion 400 mg/m2, subsequent intravenous infusions 250 mg/m2, once weekly)
Other Name: cetuximab
Drug: Comparator: irinotecan
irinotecan intravenous infusion (150 mg/m2, every other week) for 42 days
Other Name: irinotecan
Experimental: 2
Dalotuzumab administered on Day 8, 22 and 36
Drug: dalotuzumab (MK0646)
Arm 1: Dalotuzumab (10 mg/kg) intravenously administered on Day 22 and 36 Arm 2: Dalotuzumab (initial infusion 15 mg/kg, subsequent infusions 7.5 mg/kg) intravenous administered on Day 8, 22 and 36 Arm 3: Dalotuzumab (10 mg/kg) intravenously administered on Day 1, 22 and 29
Other Names:
  • dalotuzumab
  • MK0646
Drug: Comparator: cetuximab
cetuximab (initial intravenous infusion 400 mg/m2, subsequent intravenous infusions 250 mg/m2, once weekly)
Other Name: cetuximab
Drug: Comparator: irinotecan
irinotecan intravenous infusion (150 mg/m2, every other week) for 42 days
Other Name: irinotecan
Experimental: 3
Dalotuzumab administered on Day 1, 22 and 29
Drug: dalotuzumab (MK0646)
Arm 1: Dalotuzumab (10 mg/kg) intravenously administered on Day 22 and 36 Arm 2: Dalotuzumab (initial infusion 15 mg/kg, subsequent infusions 7.5 mg/kg) intravenous administered on Day 8, 22 and 36 Arm 3: Dalotuzumab (10 mg/kg) intravenously administered on Day 1, 22 and 29
Other Names:
  • dalotuzumab
  • MK0646
Drug: Comparator: cetuximab
cetuximab (initial intravenous infusion 400 mg/m2, subsequent intravenous infusions 250 mg/m2, once weekly)
Other Name: cetuximab
Drug: Comparator: irinotecan
irinotecan intravenous infusion (150 mg/m2, every other week) for 42 days
Other Name: irinotecan

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925015

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00925015     History of Changes
Other Study ID Numbers: 2009_602, MK0646-016
Study First Received: June 17, 2009
Last Updated: October 16, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Cetuximab
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014