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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: June 16, 2016
Last verified: June 2016
  Purpose
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 chemotherapynaive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.

Condition Intervention Phase
Adenocarcinoma of the Lung
Biological: Farletuzumab
Other: Placebo
Drug: Carboplatin
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Cisplatin
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-Naive 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) [ Time Frame: From date of first administration of study drug up to 6 month follow-up from randomization of the last participant i.e. cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 29 months for final analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Response rate (ORR) [ Time Frame: From Day 1 until documented radiographic progression, other protocol-approved measures of disease progression, withdrawal by participant, death due to any cause, or cut-off date of 1 Nov 2013 i.e. up to approximately 29 months for final analysis ] [ Designated as safety issue: No ]
  • Duration of Response (DR) [ Time Frame: From the first documentation of objective response (CR or PR) to the first documentation of disease progression, death due to any cause, or cut-off date of 1 Nov 2013 i.e. up to approximately 29 months for final analysis ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death due to any cause or up to cut-off date of 1 Nov 2013 (up to approximately 29 months) for final analysis ] [ Designated as safety issue: No ]
  • Number of participants with Treatment emergent adverse events (TEAEs) and Treatment emergent Serious adverse events (SAEs) [ Time Frame: For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013 i.e. up to approximately 29 months for final analysis ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: April 2011
Study Completion Date: November 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Farletuzumab plus Chemotherapy
During Combination Therapy, farletuzumab will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive farletuzumab as monotherapy until disease progression.
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 Name: MORAb-003
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/m2 will be administered intravenously
Drug: Pemetrexed
Pemetrexed 500 mg/m2 will be administered intravenously
Drug: Cisplatin
Cisplatin 75 mg/m2 will be administered intravenously
Placebo Comparator: Placebo plus Chemotherapy
During Combination Therapy, placebo will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive placebo as monotherapy 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/m2 will be administered intravenously
Drug: Pemetrexed
Pemetrexed 500 mg/m2 will be administered intravenously
Drug: Cisplatin
Cisplatin 75 mg/m2 will be administered intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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: June 16, 2016
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
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016