Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory 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).
Checked against the public recordLast updated Dec 26, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- AbbVie
- Interventions being studied
- Drug: Dexamethasone; Drug: Rovalpituzumab tesirine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Ironwood Cancer & Res Ctr /ID# 171335Chandler, Arizona
- Mayo Clinic - Scottsdale /ID# 171359Scottsdale, Arizona
- VA Central California Health C /ID# 170951Fresno, California
- Loma Linda University Medical /ID# 171377Loma Linda, California
- UC Irvine Health /ID# 171343Orange, California
- Kaiser Permanente - Roseville /ID# 200779Roseville, California
- Kaiser Permanente-Santa Clara /ID# 203024Santa Clara, California
- Kaiser Permanente Medical Ctr-Vallejo /ID# 169758Vallejo, California
- Kaiser Permanente- Walnut Creek /ID# 201305Walnut Creek, California
- Univ of Colorado Cancer Center /ID# 200810Aurora, Colorado
- Boca Raton Regional Hospital /ID# 200168Boca Raton, Florida
- UMHC/Sylvester Comprehensive /ID# 171462Deerfield Beach, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 26, 2018. Always confirm current availability with the study team.