← Back to Search

Kinase Inhibitor

Larotrectinib for Solid Cancers (NAVIGATE Trial)

Phase 2

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance Status: ECOG score ≤ 3, KPS ≥ 50% if enrolled with primary CNS tumor

Willingness to use double effective birth control methods

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120 months

Awards & highlights

NAVIGATE Trial Summary

This trial is testing how well the drug larotrectinib works on different types of cancer that have a change in the NTRK1, NTRK2, or NTRK3 gene.

Who is the study for?

This trial is for adults and children with solid tumors that have a specific gene change (NTRK1, NTRK2 or NTRK3). Participants must have tried standard treatments without success or be unlikely to benefit from them. They need at least one measurable tumor lesion, stable organ function, and no uncontrolled illnesses. People with certain infections or recent heart issues can't join.Check my eligibility

What is being tested?

The study tests larotrectinib's effectiveness on cancers with an NTRK gene fusion. Larotrectinib aims to block these genes in cancer cells to treat the disease. The trial includes patients who've had prior treatments like chemotherapy or radiation.See study design

What are the potential side effects?

While not explicitly listed here, side effects of larotrectinib may include fatigue, dizziness, nausea, liver enzyme elevation, constipation, anemia among others based on its action as a tyrosine kinase inhibitor which can affect various body systems.

NAVIGATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself but can't do any physical work or I have a brain tumor and can still do some daily activities.

Select...

I am willing to use two effective methods of birth control.

Select...

I am 18 years old or older.

Select...

My cancer has a specific gene change known as NTRK fusion.

NAVIGATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 120 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 120 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

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

Clinical benefit rate (CBR): best overall response of confirmed CR, PR, or stable disease lasting 16 or more weeks following the initiation of Larotrectinib

Comparison of PFS following initiation of larotrectinib to that following the line of therapy immediately preceding larotrectinib in each subject who has received prior therapy

+8 more

NAVIGATE Trial Design

11Treatment groups

Experimental Treatment

Group I: Arm 9_Solid tumors without confirmed NTRK fusionExperimental Treatment1 Intervention

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)

Group II: Arm 8_Other tumorsExperimental Treatment1 Intervention

Patients with e.g. kidney cancer, squamous cell cancer of head or neck or ovarian solid tumors harboring NTRK fusions (arm closed)

Group III: Arm 7_Primary CNSExperimental Treatment1 Intervention

Patients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions (arm closed)

Group IV: Arm 6_BiliaryExperimental Treatment1 Intervention

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

Group V: Arm 5_SalivaryExperimental Treatment1 Intervention

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

Group VI: Arm 4_ColorectalExperimental Treatment1 Intervention

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

Group VII: Arm 3_SarcomaExperimental Treatment1 Intervention

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

Group VIII: Arm 2_ThyroidExperimental Treatment1 Intervention

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

Group IX: Arm 1_NSCLCExperimental Treatment1 Intervention

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

Group X: Arm 11_Bone health cohortExperimental Treatment1 Intervention

Patients with all tumor types harboring NTRK fusions, not eligible for the main prospective cohort, including patients with non-measurable disease

Group XI: Arm 10_Prospective cohortExperimental Treatment1 Intervention

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)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,237 Previous Clinical Trials

25,326,763 Total Patients Enrolled

Media Library

Larotrectinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02576431 — Phase 2

Solid Tumors Research Study Groups: Arm 7_Primary CNS, Arm 3_Sarcoma, Arm 1_NSCLC, Arm 2_Thyroid, Arm 5_Salivary, Arm 8_Other tumors, Arm 10_Prospective cohort, Arm 9_Solid tumors without confirmed NTRK fusion, Arm 4_Colorectal, Arm 6_Biliary, Arm 11_Bone health cohort

Solid Tumors Clinical Trial 2023: Larotrectinib Highlights & Side Effects. Trial Name: NCT02576431 — Phase 2

Larotrectinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02576431 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other investigations have there been of BAY2757556 (Larotrectinib, Vitrakvi)?

"BAY2757556 (Larotrectinib, Vitrakvi) was first studied in 2015 by Oakland Colon Rectal Associates. So far, there have been 2 completed studies with 8 more currently recruiting patients. Many of these trials are running out of Calgary, Alberta."

Answered by AI

Are there different arms to this research project happening in various locations within the city?

"The Tom Baker Cancer Centre in Calgary, University of Texas MD Anderson Cancer Center in Houston, and London Regional Cancer Program, London Health Sciences Ctr in London are just a few of the 5 locations that are recruiting patients for this trial."

Answered by AI

What is BAY2757556 (Larotrectinib, Vitrakvi) used to treat?

"BAY2757556 (Larotrectinib, Vitrakvi) is an effective treatment option for patients with ntrk3 fusion positive, tumors, solid, and ntrk2 fusion positive."

Answered by AI

What is the potential harm that BAY2757556 (Larotrectinib, Vitrakvi) could cause individuals?

"BAY2757556 (Larotrectinib, Vitrakvi) is still in Phase 2 of clinical trials. This means that while there are some data supporting its safety, there is no information yet about whether the medication is actually effective."

Answered by AI

Is this research still recruiting participants?

"The clinical trial is actively recruiting patients, as noted on the website. The study was posted on September 30th, 2020 and updated October 11th, 2022. They are looking for 204 participants at 5 locations."

Answered by AI

How many test subjects are being included in this research?

"That is correct. The clinicaltrials.gov website mentions that this study is still actively recruiting patients. It was first posted on September 30th, 2015 and updated as recently as October 11th, 2020. They are looking for a total of 204 participants to be spread out between 5 different trial sites."

Answered by AI

Recent research and studies

Journal of Translational MedicineJournal

FGFR1 and NTRK3 Actionable Alterations in “wild-type

Shi, Eileen, Juliann Chmielecki, Chih-Min Tang, Kai Wang, Michael C. Heinrich, Guhyun Kang, Christopher L. Corless, et al.. 2016. “FGFR1 and NTRK3 Actionable Alterations in “wild-type” Gastrointestinal Stromal Tumors”. Journal of Translational Medicine. Springer Science and Business Media LLC. doi:10.1186/s12967-016-1075-6.

trkJournal

Efficacy of Larotrectinib In<i>trk</i>fusion–positive Cancers in Adults and Children

Drilon, Alexander, Theodore W. Laetsch, Shivaani Kummar, Steven G. DuBois, Ulrik N. Lassen, George D. Demetri, Michael Nathenson, et al.. 2018. “Efficacy of Larotrectinib Intrkfusion–positive Cancers in Adults and Children”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1714448.

The Lancet OncologyJournal

Larotrectinib in Patients with TRK Fusion-positive Solid Tumours: A Pooled Analysis of Three Phase 1/2 Clinical Trials

Hong, David S, Steven G DuBois, Shivaani Kummar, Anna F Farago, Catherine M Albert, Kristoffer S Rohrberg, Cornelis M van Tilburg, et al.. 2020. “Larotrectinib in Patients with TRK Fusion-positive Solid Tumours: A Pooled Analysis of Three Phase 1/2 Clinical Trials”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30856-3.

Current OncologyJournal