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
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

NCT 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