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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)

NCT00729742 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2016-04-04

No results posted yet for this study

Summary

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

Conditions

  • Carcinoma, Non-small Cell Lung

Interventions

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.

DRUG

Comparator: erlotinib monotherapy

Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-06-30
Completion
2011-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00729742 on ClinicalTrials.gov