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Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

NCT02590263 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-09-03

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Whole Brain Radiation

Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.

DRUG

Temozolomide

Temozolomide will be administered per label.

DRUG

ABT-414

ABT-414 will be administered by intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-24
Primary Completion
2020-08-27
Completion
2020-08-27

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02590263 on ClinicalTrials.gov