A Long-Term Study of Rovalpituzumab Tesirine

Study Identifier
M16-291
CT.gov Identifier
NCT03543358
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol and Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Cancer - Other
    • Study Drug
  • rovalpituzumab tesirine
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab tesirine in a parent study. * Additional eligibility criterion for Arm A: subjects who discontinued the study drug in the parent study have completed the treatment emergent adverse event reporting window. For subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including: * Tolerated their initial 2 doses of rovalpituzumab tesirine. * Achieved clinical benefit as defined by stable disease or better, and is determined that the subject would potentially benefit from additional treatment. * Experienced radiographic disease progression at least 12 weeks after the second dose of rovalpituzumab tesirine. * Received no other systemic anti-cancer therapy after rovalpituzumab tesirine treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, kidney, and liver function, per protocol. * In subjects with central nervous system (CNS) metastases, documentation of stable or improved status as described in the protocol.
    Exclusion Criteria:
    * Subjects not previously enrolled in a rovalpituzumab tesirine study.

    Protocol Summary

    The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing.

    Study Locations

    Location
    Status
    Location
    Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 204818
    Tucson, Arizona, United States, 85704
    Status
    Not applicable
    Location
    City of Hope National Medical Center /ID# 204885
    Duarte, California, United States, 91010-3012
    Status
    Not applicable
    Location
    Univ of Pittsburgh Med Ctr /ID# 204763
    Pittsburgh, Pennsylvania, United States, 15232
    Status
    Not applicable