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Clinical Trials List

Protocol Number20289
NCT Number(ClinicalTrials.gov Identfier)NCT02576431
Completed

2020-07-01 - 2026-01-30

Phase II

Recruiting3

ICD-10C7A.1

Malignant poorly differentiated neuroendocrine tumors

ICD-10C7A.8

Other malignant neuroendocrine tumors

ICD-10C7B.09

Secondary carcinoid tumors of other sites

ICD-10C7B.1

Secondary Merkel cell carcinoma

ICD-10C7B.8

Other secondary neuroendocrine tumors

ICD-10C80.0

Disseminated malignant neoplasm, unspecified

ICD-10D3A.8

Other benign neuroendocrine tumors

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9199.0

Disseminated malignant neoplasm

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

  • Trial Applicant

    BAYER TAIWAN COMPANY LTD.

  • Sponsor

    Bayer

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yu-Li Su Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kun-Huei Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NTRK Fusion-positive Tumors

Objectives

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. 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.

Test Drug

VitrakviR
VitrakviR
VitrakviR

Active Ingredient

Larotrectinib (BAY 2757556)
Larotrectinib (BAY 2757556)
Larotrectinib (BAY 2757556)

Dosage Form

Oral solution
Capsule
Capsule

Dosage

20 mg/mL
25 mg
100 mg

Endpoints

Primary Outcome Measures :
Best overall response rate by IRC [ Time Frame: Up to 120 months ]
Proportion of subjects with either complete response or partial response as determined by an independent radiology committee (IRC) using RECIST or RANO criteria.

Inclution Criteria

Inclusion Criteria:

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

Exclusion Criteria

Exclusion Criteria:

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.

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    200 participants

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