ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanded Access to ABT-414

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03123952
Expanded Access Status : Available
First Posted : April 21, 2017
Last Update Posted : March 14, 2018
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
Cancer Drug: ABT-414

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



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.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Contacts
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03123952     History of Changes
Other Study ID Numbers: C16-478
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by AbbVie:
Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme