Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
NCT ID: NCT02590263
Last Updated: 2020-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
53 participants
INTERVENTIONAL
2015-08-24
2020-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A of Phase 1 portion
ABT-414 administered every other weeks monotherapy
ABT-414
ABT-414 will be administered by intravenous infusion
Phase 2 portion
ABT-414 administered every other weeks in combination with temozolomide
Temozolomide
Temozolomide will be administered per label.
ABT-414
ABT-414 will be administered by intravenous infusion
Arm C of Phase 1 portion
ABT-414 administered every other weeks in combination with radiation and temozolomide
Whole Brain Radiation
Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.
Temozolomide
Temozolomide will be administered per label.
ABT-414
ABT-414 will be administered by intravenous infusion
Arm B of Phase 1 portion
ABT-414 administered every other weeks in combination with radiation and temozolomide
Whole Brain Radiation
Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.
Temozolomide
Temozolomide will be administered per label.
ABT-414
ABT-414 will be administered by intravenous infusion
Interventions
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Whole Brain Radiation
Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.
Temozolomide
Temozolomide will be administered per label.
ABT-414
ABT-414 will be administered by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
99 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Nagoya University Hospital /ID# 138559
Nagoya, Aichi-ken, Japan
Hiroshima University Hospital /ID# 139399
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital /ID# 150589
Sapporo, Hokkaido, Japan
University of Tsukuba Hospital /ID# 140433
Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital /ID# 149145
Shiwa-gun, Iwate, Japan
Kitasato University Hospital /ID# 148493
Sagamihara-shi, Kanagawa, Japan
Kumamoto University Hospital /ID# 138558
Kumamoto, Kumamoto, Japan
Kyoto Prefect Univ Med /ID# 149093
Kyoto, Kyoto, Japan
Kyoto University Hospital /ID# 163206
Kyoto, Kyoto, Japan
Tohoku University Hospital /ID# 138464
Sendai, Miyagi, Japan
Okayama University Hospital /ID# 148674
Okayama, Okayama-ken, Japan
Osaka University Hospital /ID# 140438
Suita-shi, Osaka, Japan
Saitama Medical University International Medical Center /ID# 140361
Hidaka-shi, Saitama, Japan
Shizuoka Cancer Center /ID# 148673
Sunto-gun, Shizuoka, Japan
Dokkyo Medical University Hospital /ID# 150990
Shimotsuga-gun, Tochigi, Japan
National Cancer Center Hospital /ID# 140435
Chuo-ku, Tokyo, Japan
Nihon University Itabashi Hospital /ID# 149385
Itabashi-ku, Tokyo, Japan
Kyorin University Hospital /ID# 140360
Mitaka-shi, Tokyo, Japan
Tokyo Women's Medical University Hospital /ID# 140436
Shinjuku-ku, Tokyo, Japan
Chiba Cancer Center /ID# 164375
Chiba, , Japan
NHO Kyoto Medical Center /ID# 140437
Kyoto, , Japan
Osaka International Cancer Institute /ID# 148494
Osaka, , Japan
Countries
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References
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Narita Y, Muragaki Y, Kagawa N, Asai K, Nagane M, Matsuda M, Ueki K, Kuroda J, Date I, Kobayashi H, Kumabe T, Beppu T, Kanamori M, Kasai S, Nishimura Y, Xiong H, Ocampo C, Yamada M, Mishima K. Safety and efficacy of depatuxizumab mafodotin in Japanese patients with malignant glioma: A nonrandomized, phase 1/2 trial. Cancer Sci. 2021 Dec;112(12):5020-5033. doi: 10.1111/cas.15153. Epub 2021 Oct 30.
Other Identifiers
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M13-714
Identifier Type: -
Identifier Source: org_study_id
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