Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

AbbVie

Status and phase: Completed; Phase 1

Conditions: Glioblastoma Multiforme

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01800695

M12-356

2012-003884-23 (EudraCT Number)

Details and patient eligibility

About

This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.

Enrollment: 202 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Glioblastoma Multiforme (GBM)
2. 70 or above on Karnofsky Performance Status
3. Adequate bone marrow function
4. Recurrent GBM per RANO criteria
5. Subjects must have confirmed EGFR amplification by central lab

Exclusion criteria

1. For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
2. For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
3. Allergies to temozolomide, dacarbazine, IgG containing agents
4. Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
5. Subjects that have had more than one disease recurrence

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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202 participants in 3 patient groups

Arm A

Experimental group

Description:

ABT-414 in combination with radiation and temozolomide

Treatment:

Drug: ABT-414

Drug: Temozolomide

Radiation: Whole Brain Radiation

Arm B

Experimental group

Description:

ABT-414 in combination with temozolomide

Treatment:

Drug: ABT-414

Drug: Temozolomide

Arm C

Experimental group

Description:

ABT-414 monotherapy

Treatment:

Drug: ABT-414