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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03334487
• Other study ID #: M16-292
• Secondary ID: 2017-003173-33
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 15, 2018
• Est. completion date: December 20, 2018

Study information

• Verified date: December 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Dexamethasone
Oral
• Rovalpituzumab tesirine
Intravenous

Locations

Country	Name	City	State
Australia	Coffs Harbour Health Campus /ID# 200642	Coffs Harbour	New South Wales
Australia	The Townsville Hospital /ID# 200640	Douglas	Queensland
Australia	Austin Hospital /ID# 200639	Heidelberg	Victoria
Australia	Perron Institute for Neurological and Translational Science /ID# 200644	Nedlands	Western Australia
Australia	The Tweed Hospital /ID# 200646	Tweed Heads	New South Wales
Australia	Border Medical /ID# 200645	Wodonga	Victoria
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	Inca /Id# 202594	Rio de Janeiro
Brazil	Instituto COI de Educacao e Pe /ID# 200499	Rio de Janeiro
Brazil	Bahia Oncology Center - NOB /ID# 201272	Salvador	Bahia
Brazil	Fundacao Antonio Prudente /ID# 200218	Sao Paulo
Brazil	Hospital de Cancer de Barretos /ID# 200104	Sao Paulo
Brazil	Icesp /Id# 201036	São Paulo	Sao Paulo
Canada	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
Germany	Charite Universitatsmedizin B- /ID# 170079	Berlin
Germany	Asklepios Fachkliniken M. Gaut /ID# 170081	Gauting
Germany	Franziskus-Hospital Harderberg /ID# 201145	Georgsmarienhütte	Niedersachsen
Germany	Thoraxklinik Heidelberg gGmbH /ID# 170078	Heidelberg
Germany	Klinikum Kassel - Onkologie /ID# 170083	Kassel
Germany	Universitatsklinikum Munster /ID# 170087	Muenster
Germany	Pius Hospital Oldenburg /ID# 170080	Oldenburg
Sweden	Gavle Hospital /ID# 171253	Gavle
Sweden	University Hospital Linkoping /ID# 201666	Linkoping
Sweden	Karolinska University Hospital /ID# 201967	Stockholm
Sweden	Norrlands Universitetssjukhus /ID# 171250	Umeå
Sweden	Akademiska Sjukhuset /ID# 171248	Uppsala	Uppsala Lan
United Kingdom	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 States	VCS, Virginia Cancer Specialis /ID# 169760	Arlington	Virginia
United States	Univ of Colorado Cancer Center /ID# 200810	Aurora	Colorado
United States	Sandra Malcolm Berman Cncr Ins /ID# 171346	Baltimore	Maryland
United States	St. Luke's Hematology Oncology /ID# 171378	Bethlehem	Pennsylvania
United States	Boca Raton Regional Hospital /ID# 200168	Boca Raton	Florida
United States	Ironwood Cancer & Res Ctr /ID# 171335	Chandler	Arizona
United States	The Ohio State University Comp /ID# 171352	Columbus	Ohio
United States	UMHC/Sylvester Comprehensive /ID# 171462	Deerfield Beach	Florida
United States	St. Luke's University Hospital /ID# 171374	Duluth	Minnesota
United States	VA Central California Health C /ID# 170951	Fresno	California
United States	Kadlec Clinic Hematology and O /ID# 169797	Kennewick	Washington
United States	Baptist Health /ID# 171379	Lexington	Kentucky
United States	Loma Linda University Medical /ID# 171377	Loma Linda	California
United States	Norton Cancer Institute /ID# 200827	Louisville	Kentucky
United States	Mount Sinai Comp Cancer Ctr /ID# 169759	Miami	Florida
United States	Tennessee Oncology PLLC: Sarah /ID# 171380	Nashville	Tennessee
United States	Vanderbilt Ingram Henry Cancer /ID# 171356	Nashville	Tennessee
United States	Tulane Cancer Center Clinic /ID# 171376	New Orleans	Louisiana
United States	UC Irvine Health /ID# 171343	Orange	California
United States	Illinois Cancer Care, PC /ID# 171310	Peoria	Illinois
United States	Kaiser Permanente - Roseville /ID# 200779	Roseville	California
United States	Kaiser Permanente-Santa Clara /ID# 203024	Santa Clara	California
United States	Mayo Clinic - Scottsdale /ID# 171359	Scottsdale	Arizona
United States	Kaiser Permanente Medical Ctr-Vallejo /ID# 169758	Vallejo	California
United States	Kaiser Permanente- Walnut Creek /ID# 201305	Walnut Creek	California
United States	Valley Hospital - Westwood, NJ /ID# 171357	Westwood	New Jersey
United States	Wake Forest Baptist Medical Center /ID# 169799	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Participant Reported Outcome EORTC QLQC15-PAL	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
Secondary	Progression Free Survival (PFS)	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
Secondary	Overall Survival (OS)	Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.	Approximately 32 months
Secondary	Objective response rate (ORR)	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
Secondary	Change in EORTC QLQ-LC-13	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
Secondary	Duration of Objective Response (DOR)	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
Secondary	Clinical Benefit Rate (CBR)	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