Trial record 9 of 233 for:    "Adenocarcinoma of lung"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01218516
First received: October 7, 2010
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

This randomized, placebo-controlled, multicenter study will test the hypothesis that farletuzumab can add to the efficacy of a platinum containing doublet in Stage IV adenocarcinoma of the lung.


Condition Intervention Phase
Adenocarcinoma of the Lung
Biological: farletuzumab
Other: Placebo
Drug: Platinum Containing Doublet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in Combination With a Platinum Containing Doublet in Chemotherapy-Naїve Subjects With Stage IV Adenocarcinoma of the Lung

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Progression-free survival (PFS) as determined by response evaluation criteria in solid tumors (RECIST) criteria version 1.1 [ Time Frame: 20 months from FPI (First Patient In) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 30 months after the last subject is randomized ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: April 2011
Study Completion Date: November 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Platinum containing doublet and farletuzumab Biological: farletuzumab

Combination Therapy: Farletuzumab (7.5 mg/kg) administered i.v. 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 i.v. on Week 1 of all additional cycles.

Monotherapy: Those subjects who experience clinical benefit from Combination Therapy (based on the investigator's assessment of tumor response) will go on to receive farletuzumab (7.5 mg/kg) i.v. administered on Week 1 of every 3-week cycle until documented radiographic progression, other protocol approved measures of disease progression, or study termination by the Sponsor.

Drug: Platinum Containing Doublet

Combination Therapy: At Week 1 of each 3-week cycle, farletuzumab or placebo will be given with one of three (3) acceptable chemotherapy regimens:

  • Carboplatin (area under the curve [AUC] 6) and paclitaxel (200 mg/m2)
  • Carboplatin (AUC 5) and pemetrexed (500 mg/m2)
  • Cisplatin (75 mg/m2) and pemetrexed (500 mg/m2) All protocol acceptable platinum containing regimens are administered on a three (3) weekly schedule for at least four (4), but no more than of six (6) cycles. Chemotherapy regimens cannot be changed once they are initiated.
Placebo Comparator: Platinum containing doublet and placebo Other: Placebo

Combination Therapy: Placebo (7.5 mg/kg) administered i.v. on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo (7.5 mg/kg) will be administered i.v. on Week 1 of all additional cycles.

Monotherapy: Those subjects who experience clinical benefit from Combination Therapy (based on the investigator's assessment of tumor response) will go on to receive placebo (7.5 mg/kg) i.v. administered on Week 1 of every 3-week cycle until documented radiographic progression, other protocol approved measures of disease progression, or study termination by the Sponsor.

Drug: Platinum Containing Doublet

Combination Therapy: At Week 1 of each 3-week cycle, farletuzumab or placebo will be given with one of three (3) acceptable chemotherapy regimens:

  • Carboplatin (area under the curve [AUC] 6) and paclitaxel (200 mg/m2)
  • Carboplatin (AUC 5) and pemetrexed (500 mg/m2)
  • Cisplatin (75 mg/m2) and pemetrexed (500 mg/m2) All protocol acceptable platinum containing regimens are administered on a three (3) weekly schedule for at least four (4), but no more than of six (6) cycles. Chemotherapy regimens cannot be changed once they are initiated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV
  • Confirmed folate receptor-alpha (FRA) expression by IHC
  • Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by CT or 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 Criteria:

  • Subjects 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218516

  Show 93 Study Locations
Sponsors and Collaborators
Morphotek
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01218516     History of Changes
Other Study ID Numbers: MORAb-003-009
Study First Received: October 7, 2010
Last Updated: May 12, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014