Oral administration after fasting/high-fat meal

VC004 Capsules

Oral administration after high-fat/fasting meal

This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate pharmacokinetics of a single oral dose of VC004 capsules under fasting and fed conditions in healthy subjects.

Food Effect Study on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects

Jiangsu vcare pharmaceutical technology co., LTD

adult patients with gastrointestinal (GI) cancer

adult patients with head and neck (H\&N) cancer

adult patients with soft tissue sarcoma (STS)

adult patients with primary central nervous system (CNS) cancer

all pediatric patients regardless of tumor type will be enrolled under this cohort

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

larotrectinib(Vitrakvi, BAY2757556)

Bayer Clinical Trials Contact

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.

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

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

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Food Effect Study on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects	NCT05528120	Locally Advance...	VC004 Capsules VC004 Capsules	18 Years - 45 Years	Jiangsu vcare pharmaceutical technology co., LTD
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	NCT04142437	Locally Advance...	larotrectinib(V...	1 Month -	Bayer

Spots Global Cancer Trial Database for locally advanced or metastatic solid tumor harboring an ntrk gene fusion