Expanded Access to Rovalpituzumab Tesirine

NCT03503890 | Unknown

• 2 other identifiers: C18-915C19-917
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Small Cell Lung Cancer

Keywords

Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme

Interventions

rovalpituzumab tesirine DRUG

intravenous

Also known as: SC16LD6.5

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant must not be eligible for a Rovalpituzumab Tesirine clinical trial.
• Pediatric participants may be evaluated on a case by case basis.

You may not qualify if:

• None.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

rovalpituzumab tesirine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 20, 2018
• Last Updated: September 10, 2019

Record last verified: 2019-09