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NCT01218516 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
A Phase 2 study of Adenocarcinoma of the Lung, sponsored by Morphotek.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT01218516 is a Phase 2 study of Adenocarcinoma of the Lung that has completed, run by Morphotek. The registered enrollment target is 130 participants, above the 45-participant average among 3 other Adenocarcinoma of the Lung trials with a reported enrollment target (189% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT01218516, a Phase 2 study of Adenocarcinoma of the Lung, has completed, sponsored by Morphotek.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study 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 or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapy naive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.
Conditions Studied
Interventions
- DRUG Carboplatin
- OTHER Placebo
- DRUG Pemetrexed
- DRUG Paclitaxel
- BIOLOGICAL Farletuzumab
Study Locations (20)
California
- Providence Health System - Beverly Hills
- Cancer Care Associates of Fresno Medical Group, Inc. - Fresno
- Medical Oncology Hematology - Gilroy
- California Cancer Care, Inc. - Greenbrae
- Moores University of California San Diego Cancer Center - La Jolla
- Wilshire Medical Oncology Group - La Verne
- Glendale Adventist Medical Center - Los Angeles
- Clinical Trials and Research Associates, Inc. - Montebello
- North Country Oncology-Hematology - Oceanside
- Pacific Hematology Oncology Associates - San Francisco
- Central Coast Medical Oncology - Santa Maria
Florida
- Center for Hematology-Oncology - Boca Raton
- Medical Specialists of the Palm Beaches - Deerfield Beach
- Broward General Medical Center - Fort Lauderdale
- Cancer Care of North Florida - Lake City
- Florida Cancer Institute-New Hope - New Port Richey
Arizona
- Ironwood Cancer and Research Center - Chandler
- Arizona Center for Hematology Oncology - Glendale
Colorado
- Rocky Mountain Cancer Centers, LLP - Denver
Connecticut
- Hematology Oncology Associates, P.C. - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2011-06-27 |
| Est. Completion | 2013-11-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01218516
The ClinicalTrials.gov registry entry for NCT01218516 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 45-participant average among 3 other Adenocarcinoma of the Lung trials with a reported enrollment target (189% higher). The listed sponsor is Morphotek, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adenocarcinoma of the Lung appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01218516 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01218516 about?
NCT01218516 is a clinical study titled "A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung". 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 or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progressio...
What is the current status of trial NCT01218516?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2011-06-27. Estimated completion is 2013-11-01.
What conditions does trial NCT01218516 study?
This clinical trial studies the following conditions: Adenocarcinoma of the Lung.
What interventions are being tested in trial NCT01218516?
The interventions under investigation include: Carboplatin (DRUG), Placebo (OTHER), Pemetrexed (DRUG), Paclitaxel (DRUG), Farletuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01218516?
This trial is sponsored by Morphotek, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01218516 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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