Trials Sponsors Conditions Drugs Pricing

Conditions

Solid Tumors Harboring NTRK Fusion Solid tumors harboring NTRK fusion

Keywords

Non-small cell lung cancerThyroid cancerSarcomaColorectal cancerSalivary gland cancerBiliary cancerCentral nervous system (CNS) TumorBreast cancerMelanomaNeurotrophic tyrosine receptor kinase (NTRK)NTRK1NTRK2NTRK3Fusion PositiveTRK fusionTRKATRKBTRKCETV6

Outcome Measures

Primary Outcomes (1)

Best overall response of confirmed complete response (CR) or partial response (PR) as determined by an independent radiology review committee using RECIST v1.1 or RANO criteria, as appropriate to tumor type.
Up to 120 months

Secondary Outcomes (11)

Best overall response of confirmed CR or PR as determined by the treating Investigator using RECIST v1.1 or RANO criteria, as appropriate to tumor type
Up to 120 months
Duration of response (DOR): determined for subjects with best overall response of confirmed CR or PR by 1) an independent radiology review committee and 2) the treating Investigator
Up to 120 months

Study Arms (11)

Arm 1_NSCLC

EXPERIMENTAL

Patients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions (arm closed)

Drug: BAY2757556 (Larotrectinib, Vitrakvi)

Arm 2_Thyroid

EXPERIMENTAL

Patients with solid thyroid tumors harboring NTRK fusions (arm closed)

Drug: BAY2757556 (Larotrectinib, Vitrakvi)

Arm 3_Sarcoma

EXPERIMENTAL

Patients with soft-tissue sarcoma harboring NTRK fusions (arm closed)

Interventions

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.

Also known as: LOXO-101

Arm 10_Prospective cohortArm 11_Bone health cohortArm 1_NSCLCArm 2_ThyroidArm 3_SarcomaArm 4_ColorectalArm 5_SalivaryArm 6_BiliaryArm 7_Primary CNS

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 equivalent certification cannot be confirmed by the Sponsor at the time of consent may have been enrolled in Cohort 9 as per protocol versions 1.0 - 8.0. From protocol version 9.0: CLIA or similar certification of the lab performing the fusion assay is required. However, patients may be included after discussion with the sponsor if the lab performing the fusion assay is not CLIA or similar certified.

Sponsors & Collaborators

Bayer
Industrylead
Bayer Consumer Care AG
Industrylead
Bayer AG

Study Sites (98)

Stanford Cancer Center Palo Alto

Palo Alto, California, 94304, United States

UCLA Health Santa Monica Cancer Care

Santa Monica, California, 90404, United States

Memorial Cancer Institute at West

Pembroke Pines, Florida, 33026, United States

The University of Chicago Medical Center - Hyde Park - Hematology & Oncology

Chicago, Illinois, 60637, United States

Mass General Cancer Center

Boston, Massachusetts, 02114-2696, United States

Dana-Farber Cancer Institute - Oncology Department

Boston, Massachusetts, 02215, United States

Memorial Sloan Kettering Cancer Center New York - Main Campus

Related Publications (20)

Waguespack SG, Drilon A, Lin JJ, Brose MS, McDermott R, Almubarak M, Bauman J, Casanova M, Krishnamurthy A, Kummar S, Leyvraz S, Oh DY, Park K, Sohal D, Sherman E, Norenberg R, Silvertown JD, Brega N, Hong DS, Cabanillas ME. Efficacy and safety of larotrectinib in patients with TRK fusion-positive thyroid carcinoma. Eur J Endocrinol. 2022 Apr 29;186(6):631-643. doi: 10.1530/EJE-21-1259.
PMID: 35333737BACKGROUND
Mascarenhas L, Ollis C, Singh Y, Menachery L, Burcoveanu DI, De La Cuesta E, van Tilburg CM, Laetsch TW. Cancer control after pausing treatment with larotrectinib in responding children with sarcoma and a TRK fusion: a plain language summary. Future Oncol. 2026 Aug 19:1-10. doi: 10.1080/14796694.2026.2711519. Online ahead of print.
PMID: 42614029DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungThyroid NeoplasmsSarcomaColorectal NeoplasmsSalivary Gland NeoplasmsBiliary Tract NeoplasmsNeoplasmsBreast NeoplasmsMelanoma

Interventions

larotrectinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract Neoplasms

Enrollment

215 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR
Expanded Access: Yes

Study Record Dates

First Submitted

October 12, 2015

First Posted

October 15, 2015

Study Start

September 30, 2015

Actual (reported)

You may not qualify if:

Investigational agent or anticancer therapy within 2 weeks prior to the planned start of larotrectinib or 5 half-lives, whichever is shorter, and without recovery of acute and/or clinically significant toxicities from that therapy.
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.
Uncontrolled concurrent malignancy that would limit assessment of efficacy of larotrectinib. Allowed conditions may include, but are not limited to in situ cancers of cervix, breast, or skin, superficial bladder cancer, limited-stage prostate cancer, and basal or squamous cancers of the skin.
Active uncontrolled systemic bacterial, viral, or fungal infection CTCAE grade ≥ 2; unstable cardiovascular disease, or other systemic disease that would limit compliance with study procedures. Unstable cardiovascular disease is defined as:
In adults, persistently uncontrolled hypertension defined as systolic blood pressure (BP) \> 150 mmHg and/or diastolic BP \> 100 mmHg despite antihypertensive therapy.
Myocardial infarction within 3 months of screening.
Stroke within 3 months of screening.
Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer
Known or suspected hypersensitivity against the active substance or any of the ingredients of the IMP.
Known history of HIV infection. All patients must be screened for HIV up to 28 days prior to study drug start using a blood test for HIV according to local regulations.
HBV or HCV infection. All patients must be screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel. Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBVDNA. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (11)

Arm 1_NSCLC

Arm 2_Thyroid

Arm 3_Sarcoma

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (98)

Related Publications (20)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Arm 4_Colorectal

Arm 5_Salivary

Arm 6_Biliary

Arm 7_Primary CNS

Arm 8_Other tumors

Arm 9_Solid tumors without confirmed NTRK fusion

Arm 10_Prospective cohort

Arm 11_Bone health cohort

You may not qualify if:

Data Sharing

Source records

Locations