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Larotrectinib for Solid Cancers
(NAVIGATE Trial)

Recruiting in Palo Alto (17 mi)

+133 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bayer

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests how well larotrectinib works for children and adults with advanced solid tumors that have specific gene changes. The drug blocks the actions of these genes to stop cancer growth.

Eligibility Criteria

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.

Inclusion Criteria

I've had standard treatments for my cancer or there are no good options left for me.

I have a brain tumor, treated before, with stable symptoms and measurable disease.

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.

See 8 more

Exclusion Criteria

Known or suspected hypersensitivity to the active substance or any IMP ingredients

I haven't taken any cancer drugs or been in a trial for 2 weeks.

My cancer progressed despite TRK inhibitor treatment.

See 4 more

Treatment Details

Interventions

Larotrectinib (Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

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)

Larotrectinib is already approved in United States, European Union, Australia for the following indications:

🇺🇸 Approved in United States as Vitrakvi for: