Expanded Access to ABT-414

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

• Registration Number: NCT03123952
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-21
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified