Status:
COMPLETED
A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
Lead Sponsor:
Morphotek
Conditions:
Adenocarcinoma of the Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin o...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV
- Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)
- Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging (MRI) scans (CT or MRI scans must have been performed within 30 days prior to the first dose of farletuzumab or placebo)
- Must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung
Exclusion
- Participants who have had previous chemotherapy for adenocarcinoma of the lung
- Prior surgery with curative intent for adenocarcinoma of the lung
- Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local radiotherapy for symptom control \[i.e., palliative radiation with non-curative intent\] is permitted)
Key Trial Info
Start Date :
June 27 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01218516
Start Date
June 27 2011
End Date
November 1 2013
Last Update
August 20 2020
Active Locations (93)
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1
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
2
Arizona Center for Hematology Oncology
Glendale, Arizona, United States, 85306-4666
3
Providence Health System
Beverly Hills, California, United States, 90210-5501
4
Cancer Care Associates of Fresno Medical Group, Inc.
Fresno, California, United States, 93720