Back to resultsExpanded Access to ABT-414
Primary Purpose
Glioblastoma or Solid Tumors, Epidermal Growth Factor Receptor (EGFR) Diagnosis
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
ABT-414
Sponsored by
About this trial
This is an expanded access trial for Glioblastoma or Solid Tumors, Epidermal Growth Factor Receptor (EGFR) Diagnosis focused on measuring Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03123952
Brief Title
Expanded Access to ABT-414
Official Title
Expanded Access to ABT-414
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma or Solid Tumors, Epidermal Growth Factor Receptor (EGFR) Diagnosis
Keywords
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ABT-414
Intervention Description
ABT-414 will be administered by intravenous infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Expanded Access to ABT-414
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