Bayer

Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion

Official Title: 
Expanded Access to Provide Selitrectinib (BAY2731954) for the Treatment of Cancers With a NTRK Gene Fusion
Brief Summary: 
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.
Available
EA Type
Individual Patients
Solid Tumors Harboring NTRK Fusion

Drug: Selitrectinib (BAY2731954)
Selitrectinib is administered as capsules or liquid formulation.
Other Name: Loxo-195

Eligibility Criteria: 

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

Eligibility Gender: 
All
Eligibility Age: 
Minimum: 1 Month
Contacts: 

Bayer Clinical Trials Contact
(+)1-888-84 22937
clinical-trials-contact@bayer.com

EA Number: 
Keywords: 
Metastatic cancer, Advanced cancer, Neurotrophic tyrosine receptor kinase (NTRK), NTRK1, NTRK2, NTRK3, Fusion Positive, Children, Loxo-195
MeSH Terms: 
9-Fluoro-15-methyl-2,11,16,20,21,24-hexaazapentacyclo(16.5.2.02,6.07,12.021,25)pentacosa-1(24),7,9,11,18(25),19,22-heptaen-17-one
Disclaimer:
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.