- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03206931
Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion
September 8, 2021 updated by: Bayer
Expanded Access to Provide Selitrectinib (BAY2731954) for the Treatment of Cancers With a NTRK Gene Fusion.
Selitrectinib expanded access is for minor and adult patients with cancer having a change in a particular gene (NTRK1, NTRK2, or NTRK3 gene fusion).
The patients are ineligible for an ongoing selitrectinib clinical trial or have other considerations that prevent access to selitrectinib through an existing clinical trial.
Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion, including blood cancers, who have previously received tropomyosin receptor kinase (TRK) inhibitor therapy.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
- Diagnosis of cancer with a NTRK1, NTRK2, and NTRK3 gene fusion
- Previous treatment with a kinase inhibitor with known activity on TRK inhibition
- Unable to participate in an ongoing selitrectinib clinical trial
- Medically suitable for treatment with selitrectinib
Exclusion Criteria:
- Currently enrolled in an ongoing clinical study with a TRK inhibitor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 29, 2017
First Submitted That Met QC Criteria
June 29, 2017
First Posted (Actual)
July 2, 2017
Study Record Updates
Last Update Posted (Actual)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 8, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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