Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04830202




Registration number
NCT04830202
Ethics application status
Date submitted
31/03/2021
Date registered
5/04/2021
Date last updated
3/04/2024

Titles & IDs
Public title
Expanded Access to Telisotuzumab Vedotin
Scientific title
Expanded Access to Telisotuzumab Vedotin
Secondary ID [1] 0 0
C20-503
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Telisotuzumab vedotin

Treatment: Drugs: Telisotuzumab vedotin
Intravenous Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- The participant must not be eligible for a telisotuzumab vedotin clinical trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Western Heamatology and Oncology Clinics /ID# 243364 - West Perth
Recruitment postcode(s) [1] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
Germany
State/province [3] 0 0
Cologne
Country [4] 0 0
Germany
State/province [4] 0 0
Gauting
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Yau Ma Tei
Country [6] 0 0
Israel
State/province [6] 0 0
Tel-Aviv
Country [7] 0 0
Israel
State/province [7] 0 0
Jerusalem
Country [8] 0 0
Israel
State/province [8] 0 0
Petakh Tikva

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04830202
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04830202