Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
NCT ID: NCT03334487
Last Updated: 2018-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2018-03-15
2018-12-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rovalpituzumab tesirine + dexamethasone
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle plus oral dexamethasone 8 mg twice daily on Day -1, Day 1, and Day 2 of 6-week each cycle.
Dexamethasone
Oral
Rovalpituzumab tesirine
Intravenous
Interventions
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Dexamethasone
Oral
Rovalpituzumab tesirine
Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Minimum life expectancy of at least 12 weeks.
* Laboratory values meeting the criteria specified in the protocol.
* Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen.
* Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue.
* Measurable disease as described per protocol.
* In participants with a history of central nervous system (CNS) metastases, documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids.
Exclusion Criteria
* Recent or on-going serious infection.
* History of other invasive malignancy that has not been in remission for at least 3 years.
* History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation.
* Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
* Documented history of capillary leak syndrome.
* Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing requirements for pericardiocentesis or thoracentesis.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Ironwood Cancer & Res Ctr /ID# 171335
Chandler, Arizona, United States
Mayo Clinic - Scottsdale /ID# 171359
Scottsdale, Arizona, United States
VA Central California Health C /ID# 170951
Fresno, California, United States
Loma Linda University Medical /ID# 171377
Loma Linda, California, United States
UC Irvine Health /ID# 171343
Orange, California, United States
Kaiser Permanente - Roseville /ID# 200779
Roseville, California, United States
Kaiser Permanente-Santa Clara /ID# 203024
Santa Clara, California, United States
Kaiser Permanente Medical Ctr-Vallejo /ID# 169758
Vallejo, California, United States
Kaiser Permanente- Walnut Creek /ID# 201305
Walnut Creek, California, United States
Univ of Colorado Cancer Center /ID# 200810
Aurora, Colorado, United States
Boca Raton Regional Hospital /ID# 200168
Boca Raton, Florida, United States
UMHC/Sylvester Comprehensive /ID# 171462
Deerfield Beach, Florida, United States
Mount Sinai Comp Cancer Ctr /ID# 169759
Miami, Florida, United States
Illinois Cancer Care, PC /ID# 171310
Peoria, Illinois, United States
Baptist Health /ID# 171379
Lexington, Kentucky, United States
Norton Cancer Institute /ID# 200827
Louisville, Kentucky, United States
Tulane Cancer Center Clinic /ID# 171376
New Orleans, Louisiana, United States
Sandra Malcolm Berman Cncr Ins /ID# 171346
Baltimore, Maryland, United States
St. Luke's University Hospital /ID# 171374
Duluth, Minnesota, United States
Valley Hospital - Westwood, NJ /ID# 171357
Westwood, New Jersey, United States
Wake Forest Baptist Medical Center /ID# 169799
Winston-Salem, North Carolina, United States
The Ohio State University Comp /ID# 171352
Columbus, Ohio, United States
St. Luke's Hematology Oncology /ID# 171378
Bethlehem, Pennsylvania, United States
Tennessee Oncology PLLC: Sarah /ID# 171380
Nashville, Tennessee, United States
Vanderbilt Ingram Henry Cancer /ID# 171356
Nashville, Tennessee, United States
VCS, Virginia Cancer Specialis /ID# 169760
Arlington, Virginia, United States
Kadlec Clinic Hematology and O /ID# 169797
Kennewick, Washington, United States
Coffs Harbour Health Campus /ID# 200642
Coffs Harbour, New South Wales, Australia
The Tweed Hospital /ID# 200646
Tweed Heads, New South Wales, Australia
The Townsville Hospital /ID# 200640
Douglas, Queensland, Australia
Austin Hospital /ID# 200639
Heidelberg, Victoria, Australia
Border Medical /ID# 200645
Wodonga, Victoria, Australia
Perron Institute for Neurological and Translational Science /ID# 200644
Nedlands, Western Australia, Australia
Bahia Oncology Center - NOB /ID# 201272
Salvador, Estado de Bahia, Brazil
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496
Ijuí, Rio Grande do Sul, Brazil
Hospital Sao Lucas da PUCRS /ID# 201258
Porto Alegre, Rio Grande do Sul, Brazil
Icesp /Id# 201036
São Paulo, São Paulo, Brazil
Inca /Id# 202594
Rio de Janeiro, , Brazil
Instituto COI de Educacao e Pe /ID# 200499
Rio de Janeiro, , Brazil
Fundacao Antonio Prudente /ID# 200218
São Paulo, , Brazil
Hospital de Cancer de Barretos /ID# 200104
São Paulo, , Brazil
Tom Baker Cancer Centre /ID# 171561
Calgary, Alberta, Canada
QE II Health Sciences Centre /ID# 171569
Halifax, Nova Scotia, Canada
London Health Sciences Centre /ID# 171567
London, Ontario, Canada
The Ottawa Hospital /ID# 200682
Ottawa, Ontario, Canada
Franziskus-Hospital Harderberg /ID# 201145
Georgsmarienhütte, Lower Saxony, Germany
Charite Universitatsmedizin B- /ID# 170079
Berlin, , Germany
Asklepios Fachkliniken M. Gaut /ID# 170081
Gauting, , Germany
Thoraxklinik Heidelberg gGmbH /ID# 170078
Heidelberg, , Germany
Klinikum Kassel - Onkologie /ID# 170083
Kassel, , Germany
Universitatsklinikum Munster /ID# 170087
Münster, , Germany
Pius Hospital Oldenburg /ID# 170080
Oldenburg, , Germany
Akademiska Sjukhuset /ID# 171248
Uppsala, Uppsala County, Sweden
Gavle Hospital /ID# 171253
Gävle, , Sweden
University Hospital Linkoping /ID# 201666
Linköping, , Sweden
Karolinska University Hospital /ID# 201967
Stockholm, , Sweden
Norrlands Universitetssjukhus /ID# 171250
Umeå, , Sweden
Leicester Royal Infirmary /ID# 201154
Leicester, England, United Kingdom
Christie NHS Foundation Trust /ID# 201149
Manchester, , United Kingdom
Royal Preston Hospital /ID# 201146
Preston, , United Kingdom
Countries
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Other Identifiers
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2017-003173-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-292
Identifier Type: -
Identifier Source: org_study_id