NCT03123952

Brief Summary

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABT-414 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

First QC Date

April 18, 2017

Last Update Submit

July 12, 2019

Conditions

Glioblastoma or Solid Tumors, Epidermal Growth Factor Receptor (EGFR) Diagnosis

Keywords

Expanded AccessPre-approval AccessCompassionate UseSpecial Access ProgramNamed Patient BasisSpecial Access Scheme

Interventions

ABT-414DRUG

ABT-414 will be administered by intravenous infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must have epidermal growth factor receptor (EGFR) amplification or EGFRvIII mutation.
  • Health Care Provider (HCP) must have prior clinical trial experience with ABT-414.
  • The participant must not be eligible for an ABT-414 clinical trial.
  • Pediatric participants may be evaluated on a case by case basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GlioblastomaDisease

Interventions

ABT-414

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissuePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2017

First Posted

April 21, 2017

Last Updated

July 15, 2019

Record last verified: 2019-07