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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

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

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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



Intervention Details:
  • Drug: ABT-414
    ABT-414 will be administered by intravenous infusion

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

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

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03123952     History of Changes
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
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs