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

Phase 1CompletedNCT01800695

AbbVie202 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

202

Conditions

Glioblastoma Multiforme

Interventions

ABT-414DRUG

ABT-414 will be administered by intravenous infusion

TemozolomideDRUG

Temozolomide will be administered per label and local prescribing regulations.

Whole Brain RadiationRADIATION

Whole Brain radiation will be administered in 30 fractions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number and percentage of participants with adverse events

Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)

Time frame: Every week for an expected average of 34 weeks

Maximum concentration of ABT-414

Measurement of the maximum concentration of ABT- 414 in the blood

Time frame: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks

Number of Dose Limiting Toxicities

Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)

Time frame: Every week for an expected average of 34 weeks

Minimum Concentration of ABT-414

Measurement of the minimum concentration of ABT-414 in the blood

Time frame: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks

Half-life of ABT-414

Measurement of the clearance of ABT-414

Time frame: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks

Secondary Outcomes

Biomarker EGFR expression

Assessment of tumor biomarkers that may correlate with efficacy.

Time frame: At screening and post-study

Progression Free Survival

Progression Free Survival per RANO criteria is the length of time during and after the treatment of a disease, that the participant lives with the disease but does not get worse.

Data from ClinicalTrials.gov

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