Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

Официальное название

PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

Обзор

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

Вмешательства

• Препарат larotrectinib(Vitrakvi, BAY2757556)
  In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol

Первичные конечные точки

• Number of participants with treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 30 days after last dose]
• Severity of TEAEs [Срок оценки: Up to 30 days after last dose]
• Seriousness of TEAEs [Срок оценки: Up to 30 days after last dose]
• Reasonable causal relationship between larotrectinib and an AE [Срок оценки: Up to 30 days after last dose]
• Causality of TEAEs [Срок оценки: Up to 30 days after last dose]
• Action taken related to larotrectinib treatment [Срок оценки: Up to 30 days after last dose]

Вторичные конечные точки (12)

• Objective response rate (ORR) [Срок оценки: Up to 8 years]
• Disease control rate (DCR) [Срок оценки: Up to 8 years]
• Duration of response (DOR) [Срок оценки: Up to 8 years]
• Time to response (TTR) [Срок оценки: Up to 8 years]
• Progression-free survival (PFS) [Срок оценки: Up to 8 years]
• Overall survival (OS) [Срок оценки: Up to 8 years]
• Total dose [Срок оценки: Up to 8 years]
• Starting and ending dose [Срок оценки: Up to 8 years]
• Dose modification during treatment [Срок оценки: Up to 8 years]
• Duration of treatment (DOT) [Срок оценки: Up to 8 years]
• ORR by patient subgroup(s) [Срок оценки: Up to 8 years]
• DCR by patient subgroup(s) [Срок оценки: Up to 8 years]

Критерии участия

Критерии включения

• Adult and pediatric (from birth to 18-year-old) patients
• Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
• Life expectancy of at least 3 months based on clinical judgement
• Decision to treat with larotrectinib made by the treating physician prior to study enrollment
• Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
• Signed informed consent form
• For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required

Критерии исключения

• Any contraindications as listed in the local approved product information
• Pregnancy
• Participation in an investigational program with interventions outside of routine clinical practice
• Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
• Patients with NTRK gene amplification or NTRK point mutation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 51 центр

• Banner Desert Medical Center — Mesa
• California Research Inst. — Los Angeles
• USC / Norris Comprehensive Cancer Center — Los Angeles
• UCLA - Mattel Children's Hospital — Los Angeles
• Hoag Memorial Hospital Presbyterian — Newport Beach
• UCSF Benioff Children's Hospital Oakland — Oakland
• Stanford Univ Med Ctr. / Lucile Packard Children's Hosp — Palo Alto
• Providence Health System - Southern California — Santa Monica
• … и ещё 43 центра

Аргентина · 1 центр

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Австралия · 1 центр

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Австрия · 1 центр

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Бельгия · 1 центр

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Бразилия · 1 центр

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Канада · 1 центр

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Китай · 1 центр

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Дания · 1 центр

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Финляндия · 1 центр

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Франция · 1 центр

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Германия · 1 центр

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Греция · 1 центр

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Ирландия · 1 центр

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Италия · 1 центр

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Япония · 1 центр

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Luxembourg · 1 центр

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Норвегия · 1 центр

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Россия · 1 центр

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Сингапур · 1 центр

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South Korea · 1 центр

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Испания · 1 центр

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Швеция · 1 центр

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Швейцария · 1 центр

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Тайвань · 1 центр

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Великобритания · 1 центр

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Публикации

• Yang JCH, Brose MS, Castro G, Kim ES, Lassen UN, Leyvraz S, Pappo A, Lopez-Rios F, Reeves JA, Fellous M, Penault-Llorca F, Rudzinski ER, Tabatabai G, Vassal G, Drilon A, Trent J. Rationale and design of ON-TRK: a novel prospective non-interventional study in patients with TRK fusion cancer treated with larotrectinib. BMC Cancer. 2022 Jun 7;22(1):625. doi: 10.1186/s12885-022-09687-x. PMID 35672677

Идентификаторы

NCT: NCT04142437 · 20324

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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