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

December 21, 2018 updated by: AbbVie

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Rovalpituzumab tesirine
Intravenous
Other Names:
  • SC16LD6.5
Drug: Dexamethasone
Oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE
Time Frame: 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.
Approximately 32 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Participant Reported Outcome EORTC QLQC15-PAL
Time Frame: 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).
Approximately 32 months
Progression Free Survival (PFS)
Time Frame: 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.
Approximately 32 months
Overall Survival (OS)
Time Frame: Approximately 32 months
Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.
Approximately 32 months
Objective response rate (ORR)
Time Frame: 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.
Approximately 32 months
Change in EORTC QLQ-LC-13
Time Frame: 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.
Approximately 32 months
Duration of Objective Response (DOR)
Time Frame: 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.
Approximately 32 months
Clinical Benefit Rate (CBR)
Time Frame: 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.
Approximately 32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M16-292
  • 2017-003173-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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