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

Withdrawn before enrolling · Phase 3

Conditions studied: Small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT03334487

Run by

AbbVie

People needed

0

Starts

2018-03-15

Expected to finish

2018-12-20

Last updated by the study team

2018-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Ironwood Cancer & Res Ctr /ID# 171335 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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