Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

Study Identifier
M13-714
CT.gov Identifier
NCT02590263
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Plain Language Summary
Available Language(s): English, Japanese
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Study Details

Medical Condition
  • Cancer - Other
    • Study Drug
  • Temozolomide
  • ABT-414
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    20 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Japanese participants with WHO grade III or IV malignant glioma * 70 or above on Karnofsky Performance Status in Arm A of Phase 1 portion and Phase 2 portion * 80 or above on Karnofsky Performance Status in Arm B and Arm C of Phase 1 portion * Adequate bone marrow function * Recurrent malignant glioma per RANO criteria in Arm A of Phase 1 portion and Phase 2 portion * Histologically proven newly diagnosed malignant glioma in Arm B and Arm C of Phase 1 portion * Participants must have confirmed EGFR amplification by central lab in Phase 2 portion
    Exclusion Criteria:
    * Anti-cancer treatment 28 days prior to study Day 1 for Arm A of Phase 1 portion and Phase 2 portion (except temozolomide therapy for newly diagnosed treatment for Phase 2 portion) * Anti-cancer treatment prior to study Day 1 for Arm B and Arm C of Phase 1 portion * Participant has received prior treatment with bevacizumabor, EGFR therapy in Arm A of Phase 1 portion and Phase 2 portion, or for recurrent glioblastoma in Phase 2 portion * Participant has a history of major immunologic reaction to any Immunoglobulin G containing agents or component of ABT-414.

    Protocol Summary

    This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health Organization (WHO) grade III or IV malignant glioma.

    Study Locations

    Location
    Status
    Location
    Nagoya University Hospital /ID# 138559
    Nagoya, Aichi-ken, Japan, 466-8560
    Status
    Not applicable
    Location
    Hiroshima University Hospital /ID# 139399
    Hiroshima, Hiroshima, Japan, 734-8551
    Status
    Not applicable
    Location
    Hokkaido University Hospital /ID# 150589
    Sapporo, Hokkaido, Japan, 060-8648
    Status
    Not applicable
    Location
    University of Tsukuba Hospital /ID# 140433
    Tsukuba, Ibaraki, Japan, 305-8576
    Status
    Not applicable
    Location
    Iwate Medical University Hospital /ID# 149145
    Shiwa-gun, Iwate, Japan, 028-3695
    Status
    Not applicable
    Location
    Kitasato University Hospital /ID# 148493
    Sagamihara-shi, Kanagawa, Japan, 252-0375
    Status
    Not applicable
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