A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer

Study Purpose

This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test selitrectinib in humans with cancer, for whom no other effective therapy exists.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Month and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Advanced solid tumor for which, in the opinion of the investigator, no other standard therapy offers greater benefit.

- A solid tumor diagnosis in the setting of: - a) a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor.

- b) a documented NTRK fusion unresponsive to a prior TRK inhibitor.

- c) a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor.

- NTRK gene fusions will be identified in a CLIA-certified (or equivalently-accredited diagnostic) laboratory.

If such a report cannot be provided, other available certifications/accreditations are required and need to be documented. Patients with infantile fibrosarcoma (IFS) or congenital mesoblastic nephroma (CMN) may be enrolled based on an ETV6+ FISH test without identifying NTRK3.

- Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 2 in adults or Karnofsky Performance Score (KPS) Score≥50% (age ≥ 16 years) or Lansky Performance Score (LPS) ≥ 40% (age < 16 years).

- Life expectancy of at least 3 months.

- Adequate hematologic, hepatic and renal function.

- Patients with stable central nervous system (CNS) primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms have been stable for 7 days prior to the first dose of selitrectinib.

- Ability to receive study drug orally or by enteral administration.

Exclusion Criteria:

- Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, repotrectinib (TPX-0005)), taletrectinib (DS-6501b/AB-106)).

Exception is in case patient presented intolerance to the second generation TRK inhibitor agent and the duration of exposure was less than 28 days. No previous treatment with selitrectinib is allowed.

- Concurrent treatment with a strong CYP3A4 inhibitor or inducer, consumption of grapefruit juice or Seville oranges, or drugs associated with QT prolongation.

- Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of selitrectinib, or prolongation of QT interval corrected for heart rate (QTc interval) >480 milliseconds within past 6 months.

- Major surgery within 7 days of enrollment.

- Uncontrolled systemic bacterial, fungal or viral infection.

- Pregnancy or lactation.

- Known hypersensitivity to selitrectinib or Ora-Sweet® SF and OraPlus® for patients receiving liquid formulation.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03215511
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bayer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Ireland, Italy, Korea, Republic of, Singapore, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Solid Tumors Harboring NTRK Fusion

Additional Details

The trial will be conducted in 2 parts: dose escalation and expansion (Phase 1) and Phase 2. The primary objective of Phase 1 is to establish the recommended dose of selitrectinib to treat neurotrophic tyrosine kinase (NTRK) fusion cancers in patients a) aged 12 years and older and b) younger than 12 years. Secondary objectives of Phase 1 are to characterize the pharmakokinetic properties of the test drug, its safety and tolerability, and to assess the objective response rate (ORR) of NTRK-tumors. The primary objective of Phase 2 is to assess the overall response rate in NTRK fusion cancer patients as determined by an independent radiology committee (IRR). Secondary objectives of Phase 2 comprise the safety and efficacy of selitrectinib at the recommended dose.

Arms & Interventions

Arms

Experimental: Phase 1: Cancer patients <12 years

Dose escalation cohorts with pediatric patients aged <12 years. Dose escalation starts with 43 mg of selitrectinib per m2 body surface twice daily.

Experimental: Phase 1: Cancer patients ≥12 years

Dose escalation cohorts with patients aged 12 years or older. Dose escalation starts with 100 mg of selitrectinib twice daily.

Experimental: Phase 2: Cancer patients_Cohort 1

Expansion cohort consisting of patients with NTRK fusion cancers showing disease progression despite treatment with a TRK inhibitor. Patients receive selitrectinib at recommended dose twice daily.

Experimental: Phase 2: Cancer patients_Cohort 2

Expansion cohort consisting of patients with NTRK fusion cancers showing intolerance or unresponsiveness to previous treatment with a TRK inhibitor. Patients receive selitrectinib at recommended dose twice daily.

Interventions

Drug: - Selitrectinib (BAY2731954)

Selitrectinib is administered as capsules or liquid formulation.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

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