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 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: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02590263      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2018 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740