Status:
COMPLETED
A Study Evaluating Dalotuzumab (MK-0646) in Combination With Erlotinib for Participants With Non-Small Cell Lung Cancer (MK-0646-007)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Carcinoma, Non-small-cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase I/IIa study to evaluate safety and efficacy of dalotuzumab (MK-0646) in combination with erlotinib in participants with recurrent Non-Small Cell Lung Cancer (NSCLC). The Phase I part o...
Detailed Description
Dalotuzumab is a humanized monoclonal antibody (mAb) that targets the Insulin-like Growth Factor Receptor (IGF-1R). Dalotuzumab may act through: * Inhibition of IGF-1-mediated cell signaling to cause...
Eligibility Criteria
Inclusion
- Participant has locally advanced or metastatic stage IIIB/IV NSCLC that has relapsed after hemotherapy/chemoratiotherapy
- Participant has had at least one chemotherapy regimen for recurrent or metastatic disease
- Participant is 18 years of age or older
- Participant has a performance status of 0-2 on Eastern Cooperative Group (ECOG) scale
- Women of childbearing potential have a negative pregnancy test
Exclusion
- Participant has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
- Participant has not recovered from adverse events from previous therapy within 4 weeks
- Participant has received EGFR-Tyrosine Kinase Inhibitor (TKI) inhibitor/anti-EGFR mAb therapy
- Participant has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
- Participant has had more than 2 systemic chemotherapies for metastatic disease
- Participant has not completed radiotherapy with complete resolution of toxicities at least 2 weeks before starting in the study
- Participant is taking part in another clinical study
- Participant has a primary central nervous system tumor
- Participant abuses drugs or alcohol
- Participant is pregnant or breastfeeding
- Participant is Human Immunodeficiency Virus (HIV) positive
- Participant has a history of hepatitis B or C
- Participant is using growth hormone or growth hormone inhibitors
Key Trial Info
Start Date :
March 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2012
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00654420
Start Date
March 19 2008
End Date
February 13 2012
Last Update
August 8 2018
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