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

NCT01218516 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-08-20

Study results available
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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

  • Adenocarcinoma of the Lung

Interventions

BIOLOGICAL

Farletuzumab

Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles. Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression.

OTHER

Placebo

Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles. Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression.

DRUG

Carboplatin

Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL\^min \[AUC5-6\].

DRUG

Paclitaxel

Paclitaxel 200 mg/m\^2 will be administered intravenously.

DRUG

Pemetrexed

Pemetrexed 500 mg/m\^2 will be administered intravenously.

DRUG

Cisplatin

Cisplatin 75 mg/m\^2 will be administered intravenously.

Sponsors & Collaborators

  • Morphotek

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-27
Primary Completion
2012-12-15
Completion
2013-11-01

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Italy
  • Poland
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT01218516 on ClinicalTrials.gov