A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer

Study Identifier
SCRX001-008
CT.gov Identifier
NCT03086239
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Lung Cancer - Small Cell Lung Cancer (SCLC)
    • Study Drug
  • Rovalpituzumab tesirine
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Histologically or cytologically confirmed advanced, recurrent small-cell lung cancer (SCLC) with documented disease progression after at least two (2) prior systemic regimens, including at least one (1) platinum-based regimen. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, hepatic and renal function.
    Exclusion Criteria:
    * No prior exposure to a pyrrolobenzodiazepine (PBD)-based drug.

    Protocol Summary

    This is a Japanese, multicenter, open-label, dose-escalation study. This is the first study to assess the safety and tolerability as well as explore the pharmacokinetics, pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants with advanced small cell lung cancer (SCLC).

    Study Locations

    Location
    Status
    Location
    National Cancer Ctr Hosp East /ID# 161432
    Kashiwa-shi, Chiba, Japan, 277-8577
    Status
    Not applicable
    Location
    Kyushu University Hospital /ID# 161430
    Fukuoka, Fukuoka, Japan, 812-8582
    Status
    Not applicable
    Location
    Kinki University -Osakasayama Campus /ID# 161431
    Osakasayama-shi, Osaka, Japan, 589-8511
    Status
    Not applicable
    Location
    National Cancer Center Hospital /ID# 161429
    Chuo-ku, Tokyo, Japan, 104-0045
    Status
    Not applicable
    Location
    Wakayama Medical University /ID# 161428
    Wakayama, Japan, 641-8510
    Status
    Not applicable