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Expanded Access to Telisotuzumab Vedotin

Primary Purpose

Non-Small Cell Lung Cancer (NSCLC)

Status
Available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Telisotuzumab vedotin
Sponsored by
AbbVie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Non-Small Cell Lung Cancer (NSCLC) focused on measuring Non-Small Cell Lung Cancer (NSCLC), Telisotuzumab vedotin, ABBV-399, Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

- The participant must not be eligible for a telisotuzumab vedotin clinical trial.

Sites / Locations

  • Sutter Medical Group /ID# 254816
  • Oncology & Hematology Specialist /ID# 248083
  • Western Heamatology and Oncology Clinics /ID# 243364
  • University Hospital Cologne /ID# 254773
  • Asklepios Fachkliniken Muenchen-Gauting /ID# 259196
  • Hong Kong United Oncology Centre /ID# 241857
  • The Chaim Sheba Medical Center /ID# 256530
  • Shaare Zedek Medical Center /ID# 252374
  • Rabin Medical Center /ID# 228611

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 31, 2021
Last Updated
July 25, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04830202
Brief Title
Expanded Access to Telisotuzumab Vedotin
Official Title
Expanded Access to Telisotuzumab Vedotin
Study Type
Expanded Access

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
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 Telisotuzumab vedotin prior to approval by the local regulatory agency. Availability will depend on territory eligibility. 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
Non-Small Cell Lung Cancer (NSCLC)
Keywords
Non-Small Cell Lung Cancer (NSCLC), Telisotuzumab vedotin, ABBV-399, 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)
Telisotuzumab vedotin
Other Intervention Name(s)
ABBV-399
Intervention Description
Intravenous Infusion

10. Eligibility

Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - The participant must not be eligible for a telisotuzumab vedotin clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Sutter Medical Group /ID# 254816
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Available
Facility Name
Oncology & Hematology Specialist /ID# 248083
City
Mountain Lakes
State/Province
New Jersey
ZIP/Postal Code
07046-1743
Country
United States
Individual Site Status
Available
Facility Name
Western Heamatology and Oncology Clinics /ID# 243364
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Individual Site Status
Available
Facility Name
University Hospital Cologne /ID# 254773
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Available
Facility Name
Asklepios Fachkliniken Muenchen-Gauting /ID# 259196
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Individual Site Status
Available
Facility Name
Hong Kong United Oncology Centre /ID# 241857
City
Yau Ma Tei
Country
Hong Kong
Individual Site Status
Available
Facility Name
The Chaim Sheba Medical Center /ID# 256530
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Available
Facility Name
Shaare Zedek Medical Center /ID# 252374
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Available
Facility Name
Rabin Medical Center /ID# 228611
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Available

12. IPD Sharing Statement

Learn more about this trial

Expanded Access to Telisotuzumab Vedotin

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