Trial record 1 of 1 for: MORAb-003-009

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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Morphotek

ClinicalTrials.gov Identifier:

NCT01218516

First received: October 7, 2010

Last updated: January 8, 2013

Last verified: January 2013

History of Changes

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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 ]

Estimated Enrollment:	120
Study Start Date:	April 2011
Estimated Study Completion Date:	January 2015
Estimated 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.

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

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:	January 8, 2013
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
Adenocarcinoma, Mucinous
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Neoplasms, Cystic, Mucinous, and Serous
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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