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UNITE Study: Understanding New Interventions With GBM ThErapy

NCT03419403 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-14

Study results available
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Summary

The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafodotin (ABT-414).

Conditions

Interventions

DRUG

Steroid eye drops

Solution, eye drop

DRUG

Vasoconstrictor eye drops

Solution, eye drop

OTHER

Cold compress

Cold compress

DRUG

Ophthalmic steroid ointment

Ointment

DRUG

Depatuxizumab mafodotin

During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles.

DRUG

Temozolomide

Temozolomide was to be administered according to the local standard of care. Duration of treatment was to be 6 - 12 cycles in the adjuvant phase and at the discretion of the investigator as supported by local standard of care.

RADIATION

Radiation

Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-30
Primary Completion
2019-09-05
Completion
2020-03-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

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 NCT03419403 on ClinicalTrials.gov