Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

AbbVie

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glioblastoma Multiforme; Malignant Glioma

Treatments: Drug: Temozolomide; Drug: ABT-414; Radiation: Whole Brain Radiation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02590263

M13-714

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 4 patient groups

Arm A of Phase 1 portion

Experimental group

Description:

ABT-414 administered every other weeks monotherapy

Treatment:

Drug: ABT-414

Phase 2 portion

Experimental group

Description:

ABT-414 administered every other weeks in combination with temozolomide

Treatment:

Drug: ABT-414

Drug: Temozolomide

Arm C of Phase 1 portion

Experimental group

Description:

ABT-414 administered every other weeks in combination with radiation and temozolomide

Treatment:

Radiation: Whole Brain Radiation

Drug: ABT-414

Drug: Temozolomide

Arm B of Phase 1 portion

Experimental group

Description:

ABT-414 administered every other weeks in combination with radiation and temozolomide

Treatment:

Radiation: Whole Brain Radiation

Drug: ABT-414

Drug: Temozolomide