Expanded Access to ABT-414

NCT ID: NCT03123952

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

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

Interventions

ABT-414

ABT-414 will be administered by intravenous infusion

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Other Identifiers

C19-919

Identifier Type: OTHER

Identifier Source: secondary_id

C16-478

Identifier Type: -

Identifier Source: org_study_id