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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01218516
Other study ID # MORAb-003-009
Secondary ID 2010-022229-13
Status Completed
Phase Phase 2
First received
Last updated
Start date June 27, 2011
Est. completion date November 1, 2013

Study information

Verified date March 2018
Source Morphotek
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date November 1, 2013
Est. primary completion date December 15, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV

- Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)

- Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging (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:

- Participants 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)

Study Design


Intervention

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].
Paclitaxel
Paclitaxel 200 mg/m^2 will be administered intravenously.
Pemetrexed
Pemetrexed 500 mg/m^2 will be administered intravenously.
Cisplatin
Cisplatin 75 mg/m^2 will be administered intravenously.

Locations

Country Name City State
Australia Royal Adelaide Hospital, Cancer Centre Adelaide South Australia
Australia Flinders Medical Centre, Dept. of Oncology Bedford Park South Australia
Australia Box Hill Hospital Box Hill Victoria
Australia Royal Brisbane and Women's Hospital, Dept. of Medical Oncology Brisbane Queensland
Australia Lyell McEwin Hospital Elizabeth Vale South Australia
Australia Frankston Hospital, Oncology Day Unit Frankston Victoria
Australia Fremantle Hospital Fremantle Western Australia
Australia Epworth Healthcare Richmond Victoria
Australia The Tweed Hospital Tweed Heads New South Wales
Australia Southern Medical Day Oncology Care Centre Wollongong New South Wales
Australia The Queen Elizabeth Hospital Woodville South South Australia
Australia Princess Alexandra Hospital Woolloongabba Queensland
Canada Royal Victoria Hospital Barrie Ontario
Canada Grand River Regional Cancer Centre Kitchener Ontario
Canada Jewish General Hospital Montréal Quebec
Canada Princess Margaret Hospital Toronto Ontario
Germany HELIOS Klinikum Emil von Behring Berlin
Germany Krankenhaus Nordwest GmbH Frankfurt am Main Hessen
Germany Asklepios Fachkliniken München-Gauting Gauting Bayern
Germany Städtisches Krankenhaus Martha-Maria Halle Dölau gGmbH Halle Sachsen-anhalt
Germany Asklepios Klinik Harburg Hamburg
Germany Universitätsklinikum Heidelberg Heidelberg Baden-wuerttemberg
Germany Klinik Löwenstein gGmbH Löwenstein Baden-wuerttemberg
Germany Johannes-Wesling-Klinikum Minden Minden Nordrhein-westfalen
Italy Istituto Nazionale per la Ricerca sul Cancro Genova
Italy Ospedale Unico Versilia Lido di Camaiore Lucca
Italy A.O. Seconda Università degli Studi di Napoli Napoli
Italy Azienda Ospedaliero-Univesitaria "San Luigi Gonzaga" Orbassano Torino
Poland Specjalistyczny Szpital im. Alfreda Sokolowskiego Szczecin Zachodniopomorskie
Poland Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Dzieciecy Torun Kujawsko-pomorskie
Poland Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie Warszawa Mazowieckie
Russian Federation Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan Kazan Tatarstan
Russian Federation Cancer Research Center n.a. N.N. Blokhin Moscow
Russian Federation City Oncology Hospital # 62 Moscow
Spain Hospital Clinic i Provincial de Barcelona Barcelona
Spain Hospital General Vall d'Hebron, Barcelona Barcelona
Spain Hospital Germans Trías i Pujol Barcelona
Spain Fundación Jiménez Díaz Madrid
Spain Hospital Regional Carlos Haya Málaga Malaga
United States Christus Saint Frances, Cabrini Hospital, Cabrini Cancer Center Alexandria Louisiana
United States Texas Oncology - Bedford Bedford Texas
United States National Cancer Institute Bethesda Maryland
United States St. Luke's Cancer Center Associates Bethlehem Pennsylvania
United States Providence Health System Beverly Hills California
United States Center for Hematology-Oncology Boca Raton Florida
United States University Hematology Oncology, Inc. Centralia Illinois
United States Ironwood Cancer and Research Center Chandler Arizona
United States University of Chicago Medical Center Chicago Illinois
United States Maryland Oncology Hematology, P.A. Columbia Maryland
United States Medical Specialists of the Palm Beaches Deerfield Beach Florida
United States Rocky Mountain Cancer Centers, LLP Denver Colorado
United States Englewood Hospital and Medical Center Englewood New Jersey
United States Willamette Valley Cancer Institute and Research Center Eugene Oregon
United States Deaconess Clinic Downtown Evansville Indiana
United States Virginia Cancer Specialists, PC Fairfax Virginia
United States Detroit Clinical Research Center Farmington Hills Michigan
United States Broward General Medical Center Fort Lauderdale Florida
United States Cancer Care Associates of Fresno Medical Group, Inc. Fresno California
United States University of Texas Medical Branch Galveston Texas
United States Gettysburg Cancer Center Gettysburg Pennsylvania
United States Medical Oncology Hematology Gilroy California
United States Arizona Center for Hematology Oncology Glendale Arizona
United States Cancer Team Bellin Health Green Bay Wisconsin
United States California Cancer Care, Inc. Greenbrae California
United States Kentucky Cancer Center Hazard Kentucky
United States Houston Cancer Institute Houston Texas
United States Queens Hospital Center Jamaica New York
United States Moores University of California San Diego Cancer Center La Jolla California
United States Wilshire Medical Oncology Group La Verne California
United States Cancer Care of North Florida Lake City Florida
United States Baptist Health System, Inc. Lexington Kentucky
United States Glendale Adventist Medical Center Los Angeles California
United States Hematology and Oncology Specialists, LLC Metairie Louisiana
United States Clinical Trials and Research Associates, Inc. Montebello California
United States The Community Hospital Munster Indiana
United States Tennessee Oncology, PLLC Nashville Tennessee
United States Florida Cancer Institute-New Hope New Port Richey Florida
United States Ocala Oncology Center, PL Ocala Florida
United States North Country Oncology-Hematology Oceanside California
United States MD Anderson Cancer Center-Orlando Orlando Florida
United States Berkshire Hematology Oncology, PC Pittsfield Massachusetts
United States Texas Oncology - Plano East Plano Texas
United States Delta Hematology Oncology Associates, PC Portsmouth Virginia
United States Pacific Hematology Oncology Associates San Francisco California
United States Central Coast Medical Oncology Santa Maria California
United States Virginia Mason Medical Center Seattle Washington
United States Medical Oncology Associates, PS Spokane Washington
United States Rockwood Cancer Treatment Center Spokane Washington
United States Hematology Oncology Associates, P.C. Stamford Connecticut
United States Northwest Cancer Center Sugar Land Texas
United States Syracuse Veterns Affairs Medical Center Syracuse New York
United States Texas Oncology - Tyler Tyler Texas
United States Texas Oncology - Waco Waco Texas

Sponsors (1)

Lead Sponsor Collaborator
Morphotek

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Italy,  Poland,  Russian Federation,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) PFS was defined as the time from the date of randomization to the date of the first observation of investigator-assessed (radiology review) progression based on Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 or other protocol-approved measures of disease progression (e.g., new occurrence of positive fluid cytology, newly diagnosed evidence of disease progression from histologic samples, PET-positive metastases, or new bone or brain metastases), or date of death, whatever the cause. Disease progression as assessed by the investigator per RECIST v1.0 was defined as at least a 20% increase in sum of longest diameters (RECIST definition) compared to baseline (or lowest sum while on study if less than baseline), or any new lesions (measurable or nonmeasurable). 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 28 months for final analysis
Secondary Overall Response Rate (ORR) ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator's radiologic assessments using RECIST 1.1 for target lesions and assessed by Magnetic resonance imaging (MRI) and computerized tomography (CT) scan (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR. 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 28 months for final analysis
Secondary Duration of Response (DR) DR was derived for those participants with objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression (ie, objective tumor progression as assessed by investigator's radiology review or other protocol-approved measures of disease progression) or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 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 28 months for final analysis
Secondary Overall Survival (OS) OS was defined as the time (in months) from the date of randomization to the date of death, regardless of cause. 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 28 months) for final analysis
Secondary Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the participant was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, TEAEs (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. 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 28 months for final analysis
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