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COMPLETED Phase 2

A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung

NCT01218516 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 130 participants
Start Date 2011-06-27
Est. Completion 2013-11-01
Phase Phase 2

Sponsor

Morphotek

6 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Morphotek, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01218516 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01218516?

The interventions under investigation include: Carboplatin (DRUG), Placebo (OTHER), Pemetrexed (DRUG), Paclitaxel (DRUG), Farletuzumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01218516?

This trial is sponsored by Morphotek, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial