Study Stopped
Strategic considerations
Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Open-Label, Single Arm, Phase 3b Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory DLL3 Expressing Small Cell Lung Cancer
2 other identifiers
interventional
N/A
7 countries
60
Brief Summary
A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (\>= Grade 3) select treatment-emergent adverse events (TEAEs).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2018
Shorter than P25 for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedStudy Start
First participant enrolled
March 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2018
CompletedDecember 26, 2018
December 1, 2018
9 months
November 3, 2017
December 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE
Number of participants with a high grade (≥ Grade 3) protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with rovalpituzumab tesirine. Severity of TEAEs will be graded at each study visit according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.
Approximately 32 months
Secondary Outcomes (7)
Change in Participant Reported Outcome EORTC QLQC15-PAL
Approximately 32 months
Progression Free Survival (PFS)
Approximately 32 months
Overall Survival (OS)
Approximately 32 months
Objective response rate (ORR)
Approximately 32 months
Change in EORTC QLQ-LC-13
Approximately 32 months
- +2 more secondary outcomes
Study Arms (1)
Rovalpituzumab tesirine + dexamethasone
EXPERIMENTALRovalpituzumab 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.
Interventions
Intravenous
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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.
You may not qualify if:
- Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III - IV within 6 months prior to first dose of study drug.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (60)
Ironwood Cancer & Res Ctr /ID# 171335
Chandler, Arizona, 85224-5665, United States
Mayo Clinic - Scottsdale /ID# 171359
Scottsdale, Arizona, 85259, United States
VA Central California Health C /ID# 170951
Fresno, California, 93703, United States
Loma Linda University Medical /ID# 171377
Loma Linda, California, 92354, United States
UC Irvine Health /ID# 171343
Orange, California, 92868-3201, United States
Kaiser Permanente - Roseville /ID# 200779
Roseville, California, 95661-3027, United States
Kaiser Permanente-Santa Clara /ID# 203024
Santa Clara, California, 95051-5173, United States
Kaiser Permanente Medical Ctr-Vallejo /ID# 169758
Vallejo, California, 94589-2441, United States
Kaiser Permanente- Walnut Creek /ID# 201305
Walnut Creek, California, 94596, United States
Univ of Colorado Cancer Center /ID# 200810
Aurora, Colorado, 80045, United States
Boca Raton Regional Hospital /ID# 200168
Boca Raton, Florida, 33486, United States
UMHC/Sylvester Comprehensive /ID# 171462
Deerfield Beach, Florida, 33442, United States
Mount Sinai Comp Cancer Ctr /ID# 169759
Miami, Florida, 33140, United States
Illinois Cancer Care, PC /ID# 171310
Peoria, Illinois, 61615, United States
Baptist Health /ID# 171379
Lexington, Kentucky, 40503-1463, United States
Norton Cancer Institute /ID# 200827
Louisville, Kentucky, 40202-3700, United States
Tulane Cancer Center Clinic /ID# 171376
New Orleans, Louisiana, 70112, United States
Sandra Malcolm Berman Cncr Ins /ID# 171346
Baltimore, Maryland, 21204, United States
St. Luke's University Hospital /ID# 171374
Duluth, Minnesota, 55802, United States
Valley Hospital - Westwood, NJ /ID# 171357
Westwood, New Jersey, 07675, United States
Wake Forest Baptist Medical Center /ID# 169799
Winston-Salem, North Carolina, 27157-0001, United States
The Ohio State University Comp /ID# 171352
Columbus, Ohio, 43210, United States
St. Luke's Hematology Oncology /ID# 171378
Bethlehem, Pennsylvania, 18015, United States
Tennessee Oncology PLLC: Sarah /ID# 171380
Nashville, Tennessee, 37203, United States
Vanderbilt Ingram Henry Cancer /ID# 171356
Nashville, Tennessee, 37212, United States
VCS, Virginia Cancer Specialis /ID# 169760
Arlington, Virginia, 22031, United States
Kadlec Clinic Hematology and O /ID# 169797
Kennewick, Washington, 99336, United States
Coffs Harbour Health Campus /ID# 200642
Coffs Harbour, New South Wales, 2450, Australia
The Tweed Hospital /ID# 200646
Tweed Heads, New South Wales, 2485, Australia
The Townsville Hospital /ID# 200640
Douglas, Queensland, 4814, Australia
Austin Hospital /ID# 200639
Heidelberg, Victoria, 3084, Australia
Border Medical /ID# 200645
Wodonga, Victoria, 3690, Australia
Perron Institute for Neurological and Translational Science /ID# 200644
Nedlands, Western Australia, 6009, Australia
Bahia Oncology Center - NOB /ID# 201272
Salvador, Estado de Bahia, 40170-110, Brazil
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Sao Lucas da PUCRS /ID# 201258
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Icesp /Id# 201036
São Paulo, São Paulo, 01246-000, Brazil
Inca /Id# 202594
Rio de Janeiro, 20231-050, Brazil
Instituto COI de Educacao e Pe /ID# 200499
Rio de Janeiro, 22793-080, Brazil
Fundacao Antonio Prudente /ID# 200218
São Paulo, 01509-000, Brazil
Hospital de Cancer de Barretos /ID# 200104
São Paulo, 14784-400, Brazil
Tom Baker Cancer Centre /ID# 171561
Calgary, Alberta, T2N 4N2, Canada
QE II Health Sciences Centre /ID# 171569
Halifax, Nova Scotia, B3H 1V7, Canada
London Health Sciences Centre /ID# 171567
London, Ontario, N6A 5A5, Canada
The Ottawa Hospital /ID# 200682
Ottawa, Ontario, K1H 8L6, Canada
Franziskus-Hospital Harderberg /ID# 201145
Georgsmarienhütte, Lower Saxony, 49124, Germany
Charite Universitatsmedizin B- /ID# 170079
Berlin, 13353, Germany
Asklepios Fachkliniken M. Gaut /ID# 170081
Gauting, 82131, Germany
Thoraxklinik Heidelberg gGmbH /ID# 170078
Heidelberg, 69126, Germany
Klinikum Kassel - Onkologie /ID# 170083
Kassel, 34125, Germany
Universitatsklinikum Munster /ID# 170087
Münster, 48149, Germany
Pius Hospital Oldenburg /ID# 170080
Oldenburg, 26121, Germany
Akademiska Sjukhuset /ID# 171248
Uppsala, Uppsala County, 751 85, Sweden
Gavle Hospital /ID# 171253
Gävle, 801 88, Sweden
University Hospital Linkoping /ID# 201666
Linköping, 58185, Sweden
Karolinska University Hospital /ID# 201967
Stockholm, SE-17176, Sweden
Norrlands Universitetssjukhus /ID# 171250
Umeå, 90185, Sweden
Leicester Royal Infirmary /ID# 201154
Leicester, England, LE1 5WW, United Kingdom
Christie NHS Foundation Trust /ID# 201149
Manchester, M20 4BX, United Kingdom
Royal Preston Hospital /ID# 201146
Preston, PR2 9HT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 3, 2017
First Posted
November 7, 2017
Study Start
March 15, 2018
Primary Completion
December 20, 2018
Study Completion
December 20, 2018
Last Updated
December 26, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.