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/Phase 2
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 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.
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
Investigator:
Contact:
Email not avaialable

Hidaka,
Japan

Facility: Saitama Med Univ Int Med Ctr
Investigator:
Contact:
Email not avaialable

Hiroshima,
Japan

Facility: Hiroshima University Hospital
Investigator:
Contact:
Email not avaialable

Kumamoto,
Japan

Facility: Kumamoto University Hospital
Investigator:
Contact:
Email not avaialable

Kyoto,
Japan

Facility: Kyoto Prefect Univ Med
Investigator:
Contact:
Email not avaialable

Kyoto,
Japan

Facility: NHO Kyoto Medical Center
Investigator:
Contact:
Email not avaialable

Mitaka,
Japan

Facility: Kyorin University Hospital
Investigator:
Contact:
Email not avaialable

Morioka,
Japan

Facility: Iwate Medical University Hosp
Investigator:
Contact:
Email not avaialable

Nagaizumi,
Japan

Facility: Shizuoka Cancer Center
Investigator:
Contact:
Email not avaialable

Okayama,
Japan

Facility: Okayama University Hospital
Investigator:
Contact:
Email not avaialable

Osaka,
Japan

Facility: Osaka Inter. Cancer Institute
Investigator:
Contact:
Email not avaialable

Sagamihara,
Japan

Facility: Kitasato University Hospital
Investigator:
Contact:
Email not avaialable

Sakyo-ku,
Japan

Facility: Kyoto University Hospital
Investigator:
Contact:
Email not avaialable

Sapporo,
Japan

Facility: Hokkaido University Hospital
Investigator:
Contact:
Email not avaialable

Sendai,
Japan

Facility: Tohoku University Hospital
Investigator:
Contact:
Email not avaialable

Shimotsuga,
Japan

Facility: Dokkyo Medical University Hosp
Investigator:
Contact:
Email not avaialable

Suita,
Japan

Facility: Osaka University Hospital
Investigator:
Contact:
Email not avaialable

Tokyo,
Japan

Facility: Tokyo Womens Med Univ Hosp
Investigator:
Contact:
Email not avaialable

Tsukuba,
Japan

Facility: Tsukuba University Hospital
Investigator:
Contact:
Email not avaialable

???, Tokyo
Japan

Facility: National Cancer Center Hosp
Investigator:
Contact:
Email not avaialable




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