Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

Official Title

A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumors

Details

The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumors harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1-3 in children and adults.

Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumor types.

Keywords

Solid Tumors Harboring NTRK Fusion Non-small cell lung cancer Thyroid cancer Sarcoma Colorectal cancer Salivary gland cancer Biliary cancer Central nervous system (CNS) Tumor Breast cancer Melanoma Neurotrophic tyrosine receptor kinase (NTRK) NTRK1 NTRK2 NTRK3 Fusion Positive TRK fusion TRKA TRKB TRKC ETV6 Neoplasms BAY2757556 (Larotrectinib, Vitrakvi)

Eligibility

You can join if…

Open to people ages 12 years and up

  • Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion identified through molecular assays
  • Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy
  • Subjects must have at least one measurable lesion as defined by RECIST v1.1

You CAN'T join if...

  • Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK. Subjects who received less than 28 days of treatment and discontinued because of intolerance or toxicity are eligible.
  • Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain metastases are eligible to participate in the study.) Subjects with primary CNS tumors are eligible.
  • Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease, or other systemic disease that would limit compliance with study procedures.
  • Pregnancy or lactation.

Locations

  • UCLA-Santa Monica Medical Center in progress, not accepting new patients
    Santa Monica California 90404 United States
  • Stanford Cancer Center in progress, not accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bayer
ID
NCT02576431
Phase
Phase 2
Study Type
Interventional
Last Updated