Back to resultsExpanded Access to Rovalpituzumab Tesirine
Primary Purpose
Small Cell Lung Cancer
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
rovalpituzumab tesirine
Sponsored by
About this trial
This is an expanded access trial for Small Cell Lung Cancer focused on measuring Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03503890
Brief Title
Expanded Access to Rovalpituzumab Tesirine
Official Title
Expanded Access to Rovalpituzumab Tesirine
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
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)
rovalpituzumab tesirine
Other Intervention Name(s)
SC16LD6.5
Intervention Description
intravenous
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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 Rovalpituzumab Tesirine
We'll reach out to this number within 24 hrs