Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02590263 : Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
PhasePhase 1
AgesMin: 20 Years Max: 99 Years
Eligibility
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 bevacizumab or 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.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02590263      |      Link to official Clinicaltrials.gov listing
Locations
Chiba,
Japan

Facility: Chiba Cancer Center /ID# 164375
Investigator:
Contact:
Email not avaialable

Hidaka-shi,
Japan

Facility: Saitama Medical University International Medical Center /ID# 140361
Investigator:
Contact:
Email not avaialable

Hiroshima,
Japan

Facility: Hiroshima University Hospital /ID# 139399
Investigator:
Contact:
Email not avaialable

Itabashi-ku,
Japan

Facility: Nihon University Itabashi Hospital /ID# 149385
Investigator:
Contact:
Email not avaialable

Kumamoto-shi,
Japan

Facility: Kumamoto University Hospital /ID# 138558
Investigator:
Contact:
Email not avaialable

Kyoto,
Japan

Facility: Kyoto University Hospital /ID# 163206
Investigator:
Contact:
Email not avaialable

Kyoto-shi,
Japan

Facility: Kyoto Prefectural University of Medicine /ID# 149093
Investigator:
Contact:
Email not avaialable

Kyoto-shi,
Japan

Facility: National Hospital Organization Kyoto Medical Center /ID# 140437
Investigator:
Contact:
Email not avaialable

Mitaka-shi,
Japan

Facility: Kyorin University Hospital /ID# 140360
Investigator:
Contact:
Email not avaialable

Morioka-shi,
Japan

Facility: Iwate Medical University Hospital /ID# 149145
Investigator:
Contact:
Email not avaialable

Nagaizumi-cho,
Japan

Facility: Shizuoka Cancer Center /ID# 148673
Investigator:
Contact:
Email not avaialable

Nagoya-shi, Aichi,
Japan

Facility: Nagoya University Hospital /ID# 138559
Investigator:
Contact:
Email not avaialable

Okayama-shi,
Japan

Facility: Okayama University Hospital /ID# 148674
Investigator:
Contact:
Email not avaialable

Osaka,
Japan

Facility: Osaka International Cancer Institute /ID# 148494
Investigator:
Contact:
Email not avaialable

Sagamihara-shi,
Japan

Facility: Kitasato University Hospital /ID# 148493
Investigator:
Contact:
Email not avaialable

Sapporo,
Japan

Facility: Hokkaido University Hospital /ID# 150589
Investigator:
Contact:
Email not avaialable

Sendai-shi,
Japan

Facility: Tohoku University Hospital /ID# 138464
Investigator:
Contact:
Email not avaialable

Shimotsuga-gun,
Japan

Facility: Dokkyo Medical University Hospital /ID# 150990
Investigator:
Contact:
Email not avaialable

Suita-shi,
Japan

Facility: Osaka University Graduate School of Medicine /ID# 140438
Investigator:
Contact:
Email not avaialable

Tokyo,
Japan

Facility: National Cancer Center Hospital /ID# 140435
Investigator:
Contact:
Email not avaialable

Tokyo,
Japan

Facility: Tokyo Women's Medical University Hospital /ID# 140436
Investigator:
Contact:
Email not avaialable

Tsukuba,
Japan

Facility: Tsukuba University Hospital /ID# 140433
Investigator:
Contact:
Email not avaialable




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