Summary

for people ages 18 years and up (full criteria)
at UC Irvine
study started
estimated completion:

Description

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).

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

Keywords

Small Cell Lung Cancer Cancer Relapsed Small Cell Lung Cancer Remitting Small Cell Lung Cancer Delta-like protein 3 (DLL3) DLL3 Expressing Small Cell Lung Cancer Rovalpituzumab Tesirine Lung Neoplasms Small Cell Lung Carcinoma Dexamethasone acetate Dexamethasone BB 1101 Rovalpituzumab tesirine + dexamethasone

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • UC Irvine Health /ID# 171343 not yet accepting patients
    Orange California 92868-3201 United States
  • VA Central California Health C /ID# 170951 not yet accepting patients
    Fresno California 93703 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03334487
Phase
Phase 3
Study Type
Interventional
Last Updated