Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

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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)

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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