Status:
WITHDRAWN
Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Lead Sponsor:
AbbVie
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 eval...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03334487
Start Date
March 15 2018
End Date
December 20 2018
Last Update
December 26 2018
Active Locations (60)
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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