Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

• Status: Completed
• Trial end date: 2020-08-27
• Target enrollment: 0
• Participant gender: All

Summary

This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health Organization (WHO) grade III or IV malignant glioma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Dacarbazine; Temozolomide

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.