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Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729742
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : April 4, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).

Condition or disease Intervention/treatment Phase
Carcinoma, Non-small Cell Lung Drug: Comparator: erlotinib + dalotuzumab Drug: Comparator: erlotinib monotherapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer
Study Start Date : February 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Part 1
Drug: Comparator: erlotinib monotherapy
Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.
Other Name: TARCEVA®

Experimental: Part 2
erlotinib + dalotuzumab
Drug: Comparator: erlotinib + dalotuzumab

Part II: All patients will receive 1 week of erlotinib 150 mg tablets per day.

Arm 1: Patients who experience a PET response will continue on erlotinib monotherapy until disease progression.

Arm 2: Patients who fail to receive a PET response will continue to take erlotinib in combination with dalotuzumab 10 mg/kg IV infusion once weekly. At the time of disease progression, patients on erlotinib monotherapy will be offered to crossover to dalotuzumab 10 mg/kg IV infusion once weekly in combination with erlotinib.

Other Name: TARCEVA®

Primary Outcome Measures :
  1. Validate imaging platform and molecular markers [ Time Frame: FDG response at Weeks 1 and 3 following chemotherapy ]

Secondary Outcome Measures :
  1. Progression-free survival, overall survival [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
  • Patient has measurable disease
  • Patient has accessible tumor and consents to undergo a tumor biopsy [Part II only]
  • Patient is 18 years of age or older
  • Patient has a performance status of 0-2 on ECOG scale
  • Women of childbearing potential have a negative pregnancy test
  • Patients in Part I must: 1. be a female non-smoker with non-squamous histology who has had one or two prior systemic chemotherapies or 2. have documented EGFR mutation or EGFR gene amplification, regardless of demographic or clinical characteristics, who have had no more than two prior systemic chemotherapies.
  • Patients in Part II must have had one or two chemotherapy regimens for recurrent or metastatic disease

Exclusion Criteria:

  • Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
  • Patient has not recovered from adverse events from previous therapy within 4 weeks
  • Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
  • Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
  • Patient has untreated brain metastases
  • Patient has had radiotherapy to a field that affects the chest or abdomen, or thoracic surgery within 3 months prior to entering the study
  • Patient is taking part in another clinical study
  • Patient abuses drugs or alcohol
  • Patient is pregnant or breastfeeding
  • Subject is HIV positive
  • Patient has active hepatitis
  • Patient is using growth hormone or growth hormone inhibitors
  • Patient has poorly controlled diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00729742

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00729742    
Other Study ID Numbers: 0646-008
CTRI/2009/091/000139 ( Registry Identifier: CTRI )
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action