Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
Launched by ABBVIE · Oct 27, 2015
Trial Information
Current as of June 18, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility 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.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nagoya Shi, Aichi, Japan
Hiroshima Shi, Hiroshima, Japan
Sapporo Shi, Hokkaido, Japan
Tsukuba Shi, Ibaraki, Japan
Shiwa Gun, Iwate, Japan
Sagamihara Shi, Kanagawa, Japan
Kumamoto Shi, Kumamoto, Japan
Kyoto Shi, Kyoto, Japan
Kyoto Shi, Kyoto, Japan
Sendai Shi, Miyagi, Japan
Okayama Shi, Okayama, Japan
Suita Shi, Osaka, Japan
Hidaka Shi, Saitama, Japan
Sunto Gun, Shizuoka, Japan
Shimotsuga Gun, Tochigi, Japan
Chuo Ku, Tokyo, Japan
Itabashi Ku, Tokyo, Japan
Mitaka Shi, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Chiba, , Japan
Kyoto, , Japan
Osaka, , Japan
Patients applied
Trial Officials
AbbVie Inc.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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