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Expanded Access to Rovalpituzumab Tesirine

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ClinicalTrials.gov Identifier: NCT03503890
Expanded Access Status : Available
First Posted : April 20, 2018
Last Update Posted : June 12, 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 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.

Condition or disease Intervention/treatment
Small Cell Lung Cancer Drug: rovalpituzumab tesirine

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 Rovalpituzumab Tesirine



Intervention Details:
  • Drug: rovalpituzumab tesirine
    intravenous
    Other Name: SC16LD6.5

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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): NCT03503890


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: NCT03503890     History of Changes
Other Study ID Numbers: C18-915
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases