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Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

Sponsor
AbbVie (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03334487
Collaborator
(none)
0
Enrollment
60
Locations
1
Arm
9.2
Actual Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 15, 2018
Actual Primary Completion Date :
Dec 20, 2018
Actual Study Completion Date :
Dec 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Dexamethasone
Oral

Drug: Rovalpituzumab tesirine
Intravenous
Other Names:
  • SC16LD6.5

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE [Approximately 32 months]

      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.

    Secondary Outcome Measures

    1. Change in Participant Reported Outcome EORTC QLQC15-PAL [Approximately 32 months]

      The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Palliative Cancer (EORTC QLQ-C15-PAL) is a 15-item self-report questionnaire composed of 4 multi-item scales (physical & emotional functioning, fatigue and pain) along with 6 individual items (nausea & vomiting, dyspnea, insomnia, appetite loss, constipation, and global quality of life).

    2. Progression Free Survival (PFS) [Approximately 32 months]

      PFS is based on independent review of radiographic assessment, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier.

    3. Overall Survival (OS) [Approximately 32 months]

      Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.

    4. Objective response rate (ORR) [Approximately 32 months]

      ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    5. Change in EORTC QLQ-LC-13 [Approximately 32 months]

      The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ-LC 13) is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients.

    6. Duration of Objective Response (DOR) [Approximately 32 months]

      DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first.

    7. Clinical Benefit Rate (CBR) [Approximately 32 months]

      CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD) according to RECIST version 1.1.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ironwood Cancer & Res Ctr /ID# 171335 Chandler Arizona United States 85224-5665
    2 Mayo Clinic - Scottsdale /ID# 171359 Scottsdale Arizona United States 85259
    3 VA Central California Health C /ID# 170951 Fresno California United States 93703
    4 Loma Linda University Medical /ID# 171377 Loma Linda California United States 92354
    5 UC Irvine Health /ID# 171343 Orange California United States 92868-3201
    6 Kaiser Permanente - Roseville /ID# 200779 Roseville California United States 95661-3027
    7 Kaiser Permanente-Santa Clara /ID# 203024 Santa Clara California United States 95051-5173
    8 Kaiser Permanente Medical Ctr-Vallejo /ID# 169758 Vallejo California United States 94589-2441
    9 Kaiser Permanente- Walnut Creek /ID# 201305 Walnut Creek California United States 94596
    10 Univ of Colorado Cancer Center /ID# 200810 Aurora Colorado United States 80045
    11 Boca Raton Regional Hospital /ID# 200168 Boca Raton Florida United States 33486
    12 UMHC/Sylvester Comprehensive /ID# 171462 Deerfield Beach Florida United States 33442
    13 Mount Sinai Comp Cancer Ctr /ID# 169759 Miami Florida United States 33140
    14 Illinois Cancer Care, PC /ID# 171310 Peoria Illinois United States 61615
    15 Baptist Health /ID# 171379 Lexington Kentucky United States 40503-1463
    16 Norton Cancer Institute /ID# 200827 Louisville Kentucky United States 40202-3700
    17 Tulane Cancer Center Clinic /ID# 171376 New Orleans Louisiana United States 70112
    18 Sandra Malcolm Berman Cncr Ins /ID# 171346 Baltimore Maryland United States 21204
    19 St. Luke's University Hospital /ID# 171374 Duluth Minnesota United States 55802
    20 Valley Hospital - Westwood, NJ /ID# 171357 Westwood New Jersey United States 07675
    21 Wake Forest Baptist Medical Center /ID# 169799 Winston-Salem North Carolina United States 27157-0001
    22 The Ohio State University Comp /ID# 171352 Columbus Ohio United States 43210
    23 St. Luke's Hematology Oncology /ID# 171378 Bethlehem Pennsylvania United States 18015
    24 Tennessee Oncology PLLC: Sarah /ID# 171380 Nashville Tennessee United States 37203
    25 Vanderbilt Ingram Henry Cancer /ID# 171356 Nashville Tennessee United States 37212
    26 VCS, Virginia Cancer Specialis /ID# 169760 Arlington Virginia United States 22031
    27 Kadlec Clinic Hematology and O /ID# 169797 Kennewick Washington United States 99336
    28 Coffs Harbour Health Campus /ID# 200642 Coffs Harbour New South Wales Australia 2450
    29 The Tweed Hospital /ID# 200646 Tweed Heads New South Wales Australia 2485
    30 The Townsville Hospital /ID# 200640 Douglas Queensland Australia 4814
    31 Austin Hospital /ID# 200639 Heidelberg Victoria Australia 3084
    32 Border Medical /ID# 200645 Wodonga Victoria Australia 3690
    33 Perron Institute for Neurological and Translational Science /ID# 200644 Nedlands Western Australia Australia 6009
    34 Bahia Oncology Center - NOB /ID# 201272 Salvador Bahia Brazil 40170-110
    35 Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496 Ijuí Rio Grande Do Sul Brazil 98700-000
    36 Hospital Sao Lucas da PUCRS /ID# 201258 Porto Alegre Rio Grande Do Sul Brazil 90610-000
    37 Icesp /Id# 201036 São Paulo Sao Paulo Brazil 01246-000
    38 Inca /Id# 202594 Rio de Janeiro Brazil 20231-050
    39 Instituto COI de Educacao e Pe /ID# 200499 Rio de Janeiro Brazil 22793-080
    40 Fundacao Antonio Prudente /ID# 200218 Sao Paulo Brazil 01509-000
    41 Hospital de Cancer de Barretos /ID# 200104 Sao Paulo Brazil 14784-400
    42 Tom Baker Cancer Centre /ID# 171561 Calgary Alberta Canada T2N 4N2
    43 QE II Health Sciences Centre /ID# 171569 Halifax Nova Scotia Canada B3H 1V7
    44 London Health Sciences Centre /ID# 171567 London Ontario Canada N6A 5A5
    45 The Ottawa Hospital /ID# 200682 Ottawa Ontario Canada K1H 8L6
    46 Franziskus-Hospital Harderberg /ID# 201145 Georgsmarienhütte Niedersachsen Germany 49124
    47 Charite Universitatsmedizin B- /ID# 170079 Berlin Germany 13353
    48 Asklepios Fachkliniken M. Gaut /ID# 170081 Gauting Germany 82131
    49 Thoraxklinik Heidelberg gGmbH /ID# 170078 Heidelberg Germany 69126
    50 Klinikum Kassel - Onkologie /ID# 170083 Kassel Germany 34125
    51 Universitatsklinikum Munster /ID# 170087 Muenster Germany 48149
    52 Pius Hospital Oldenburg /ID# 170080 Oldenburg Germany 26121
    53 Akademiska Sjukhuset /ID# 171248 Uppsala Uppsala Lan Sweden 751 85
    54 Gavle Hospital /ID# 171253 Gavle Sweden 801 88
    55 University Hospital Linkoping /ID# 201666 Linkoping Sweden 58185
    56 Karolinska University Hospital /ID# 201967 Stockholm Sweden SE-17176
    57 Norrlands Universitetssjukhus /ID# 171250 Umeå Sweden 90185
    58 Leicester Royal Infirmary /ID# 201154 Leicester England United Kingdom LE1 5WW
    59 Christie NHS Foundation Trust /ID# 201149 Manchester United Kingdom M20 4BX
    60 Royal Preston Hospital /ID# 201146 Preston United Kingdom PR2 9HT

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03334487
    Other Study ID Numbers:
    • M16-292
    • 2017-003173-33
    First Posted:
    Nov 7, 2017
    Last Update Posted:
    Dec 26, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Cancer
    Small Cell Lung Cancer
    Relapsed Small Cell Lung Cancer
    Remitting Small Cell Lung Cancer
    Delta-like protein 3 (DLL3)
    DLL3 Expressing Small Cell Lung Cancer
    Rovalpituzumab Tesirine
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Dexamethasone

    Study Results

    No Results Posted as of Dec 26, 2018