Expanded Access to ABT-414

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ClinicalTrials.gov Identifier: NCT03123952

Expanded Access Status : No longer available

First Posted : April 21, 2017

Last Update Posted : July 15, 2019

Sponsor:

Information provided by (Responsible Party):

AbbVie

Study Description

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.

Condition or disease	Intervention/treatment
Glioblastoma or Solid Tumors, Epidermal Growth Factor Receptor (EGFR) Diagnosis	Drug: ABT-414

Study Design

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Study Type :	Expanded Access
Expanded Access Type :	Individual Patients, Intermediate-size Population
	See clinical trials of the intervention/treatment in this expanded access record.
Official Title:	Expanded Access to ABT-414

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Neuroepithelioma

U.S. FDA: Expanded Access (Compassionate Use)

U.S. FDA Resources

Interventions

Intervention Details:

Drug: ABT-414
ABT-414 will be administered by intravenous infusion

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123952

Sponsors and Collaborators

AbbVie

Investigators

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Study Director:	AbbVie Inc.	AbbVie

More Information

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Responsible Party:	AbbVie
ClinicalTrials.gov Identifier:	NCT03123952
Other Study ID Numbers:	C16-478 C19-919 ( Other Identifier: AbbVie )
First Posted:	April 21, 2017 Key Record Dates
Last Update Posted:	July 15, 2019
Last Verified:	July 2019

Keywords provided by AbbVie:


Expanded Access Pre-approval Access Compassionate Use	Special Access Program Named Patient Basis Special Access Scheme

Additional relevant MeSH terms:

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Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors	Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue

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