Expanded Access to Rovalpituzumab Tesirine
September 9, 2019 updated by: AbbVie
This is an expanded access program (EAP) for eligible participants.
This program is designed to provide access to Rovalpituzumab Tesirine 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.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
- Intermediate-size Population
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The participant must not be eligible for a Rovalpituzumab Tesirine clinical trial.
- Pediatric participants may be evaluated on a case by case basis.
Exclusion Criteria:
- None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 11, 2018
First Submitted That Met QC Criteria
April 19, 2018
First Posted (Actual)
April 20, 2018
Study Record Updates
Last Update Posted (Actual)
September 10, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C18-915
- C19-917 (Other Grant/Funding Number: AbbVie)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.