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BAY2757556 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1_NSCLC | EXPERIMENTAL | Patients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions (arm closed) |
| Arm 2_Thyroid | EXPERIMENTAL | Patients with solid thyroid tumors harboring NTRK fusions (arm closed) |
| Arm 3_Sarcoma | EXPERIMENTAL | Patients with soft-tissue sarcoma harboring NTRK fusions (arm closed) |
| Arm 4_Colorectal | EXPERIMENTAL | Patients with solid colorectal tumors harboring NTRK fusions (arm closed) |
| Arm 5_Salivary | EXPERIMENTAL | Patients with solid salivary tumors harboring NTRK fusions (arm closed) |
| Arm 6_Biliary | EXPERIMENTAL | Patients with solid biliary tumors harboring NTRK fusions (arm closed) |
| Arm 7_Primary CNS | EXPERIMENTAL | Patients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions (arm closed) |
| Arm 8_Other tumors | EXPERIMENTAL | Patients with e.g. kidney cancer, squamous cell cancer of head or neck or ovarian solid tumors harboring NTRK fusions (arm closed) |
| Arm 9_Solid tumors without confirmed NTRK fusion | EXPERIMENTAL | Patients eligible for arms 1 to 8, but with documented NTRK fusion from a laboratory where CLIA or equivalent certification cannot be confirmed by the sponsor at the time of consent (arm closed) |
| Arm 10_Prospective cohort | EXPERIMENTAL | Patients with melanoma, non secretory breast and colorectal cancer or other tumor types harboring NTRK fusions, except soft tissue sarcoma, salivary gland and thyroid cancer (arm closed) |
| Arm 11_Bone health cohort | EXPERIMENTAL | Patients with all tumor types harboring NTRK fusions, not eligible for the main prospective cohort, including patients with non-measurable disease |
| Name | Type | Description |
|---|---|---|
| BAY2757556 (Larotrectinib, Vitrakvi) | DRUG | Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles. |
Inclusion Criteria: * Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories. Subjects who have an NTRK gene fusion identified in a lab where CLIA or equivalen...
BAY2757556 is used to treat solid tumors that harbor an NTRK fusion, a genetic alteration that drives tumor growth. It is being studied in adults and children with these fusion-positive tumors across a broad range of cancer types, rather than a single organ-specific cancer.
Yes. BAY2757556 is the same compound as larotrectinib, which is also known by the brand name Vitrakvi. The names refer to the same small molecule, so search results and trial records for larotrectinib or Vitrakvi describe the same drug asset.
Bayer AG develops BAY2757556. Bayer trades on the OTC market under the ticker BAYRY. The company is the sponsor behind the clinical program evaluating the drug in NTRK fusion-positive solid tumors.
BAY2757556 has been evaluated in a Phase 2 clinical trial. That study, NCT02576431, is listed as completed and enrolled 215 participants. The program is biomarker-selected, meaning patients are chosen based on the presence of an NTRK fusion in their tumor.
BAY2757556 was studied in NCT02576431, titled A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors. The Phase 2 trial is completed, enrolled 215 patients, used a controlled design without randomization or double blinding, and ran across 25 countries.