Clinical trials: NTRK Gene Fusion
Advanced Solid Malignant Tumors
Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors
This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.
- Trial name
- NCT02675491
- Testing
- DS-6051b
- Where
- 3 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Non-Small Cell Lung Cancer
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple…
- Trial name
- ORCHARD (NCT03944772)
- Testing
- Osimertinib, Savolitinib, Gefitinib
- Where
- 47 sites in United States, Denmark and 7 more
- Volunteers
- 247 people
- Sponsor
- AstraZeneca
Solid Tumors Harboring NTRK Fusion
A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children
The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3).
- Trial name
- SCOUT (NCT02637687)
- Testing
- Larotrectinib (Vitrakvi, BAY2757556)
- Where
- 45 sites in United States, Australia and 19 more
- Volunteers
- 154 people
- Sponsor
- Bayer
Solid Tumors Harboring NTRK Fusion
A Study Called VICTORIA to Learn More About How Well Larotrectinib Works in Adults With TRK Fusion-positive Cancer by Comparing Larotrectinib Data From Clinical Studies With Data of Other Treatments From Actual Practice
This is an observational study in which patient data from the past of adult people with solid tumors harboring NTRK gene fusion are studied.
- Trial name
- NCT05192642
- Testing
- Larotrectinib(Vitrakvi, BAY2757556), Data on other treatments
- Where
- United States
- Volunteers
- 368 people
- Sponsor
- Bayer
Locally Advanced or Metastatic Infantile Fibrosarcoma Harboring an NTRK Gene Fusion, Infantile Fibrosarcoma
A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database
This is an observational study in which data from the past of children and young people with a specific cancer, called NTRK gene fusion positive infantile fibrosarcoma (IFS) is studied.
- Trial name
- EPI VITRAKVI (NCT05236257)
- Testing
- Larotrectinib (Vitrakvi, BAY2757556), Standard of Care
- Where
- France
- Volunteers
- 93 people
- Sponsor
- Bayer
Solid Tumor, Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations
Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors
The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.
- Conditions
- Solid Tumor, Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations, Tenosynovial Giant Cell Tumor
- Trial name
- NCT01804530
- Testing
- PLX7486 TsOH
- Where
- 4 sites in United States
- Volunteers
- 59 people
- Sponsor
- Plexxikon
Solid Tumors Harboring NTRK Fusion
Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion
Selitrectinib expanded access is for minor and adult patients with cancer having a change in a particular gene (NTRK1, NTRK2, or NTRK3 gene fusion).
- Trial name
- NCT03206931
- Testing
- Selitrectinib (BAY2731954)
- Sponsor
- Bayer
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
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
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…
- Trial name
- ON-TRK (NCT04142437)
- Testing
- larotrectinib(Vitrakvi, BAY2757556)
- Where
- 47 sites in United States, Argentina and 13 more
- Volunteers
- 54 people
- Sponsor
- Bayer
Tumors Harboring NTRK Fusion
Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion
Larotrectinib expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion, who are ineligible for an ongoing larotrectinib clinical trial or have other considerations that prevent access to larotrectinib…
- Trial name
- NCT03025360
- Testing
- Larotrectinib (Vitrakvi, BAY2757556)
- Sponsor
- Bayer
Solid Tumors Harboring NTRK Fusion
A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors
This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3).
- Trial name
- NAVIGATE (NCT02576431)
- Testing
- BAY2757556 (Larotrectinib, Vitrakvi)
- Where
- 98 sites in United States, Argentina and 23 more
- Volunteers
- 215 people
- Sponsor
- Bayer
Locally Advanced or Metastatic Solid Tumors, Locally Advanced or Metastatic Non-small Cell Lung Cancer
A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors
A phase I/II study to examine the safety, tolerability, pharmacokinetics and efficacy of XZP-5955 tablets in patients with advanced solid tumors harboring NTRK or ROS1 gene fusion
- Trial name
- NCT04996121
- Testing
- XZP-5955 tablets
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Cancers With NTRK, ROS1, or ALK Gene Fusions
Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions
Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for…
- Trial name
- NCT03066661
- Testing
- Entrectinib
- Where
- United States
- Sponsor
- Hoffmann-La Roche
Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.
This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations.
- Trial name
- NCT04671849
- Testing
- SIM1803-1A
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Non-Small Cell Lung Cancer
Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion
This observational study evaluates the real-world safety and effectiveness of repotrectinib in Korean participants with locally advanced or metastatic ROS1-positive non-small cell lung cancer or solid tumors harboring…
- Trial name
- NCT07599007
- Testing
- Repotrectinib
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer, Cholangiocarcinoma
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)
This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion.
- Conditions
- Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms
- Trial name
- STARTRK-2 (NCT02568267)
- Testing
- Entrectinib
- Where
- 120 sites in United States, Australia and 14 more
- Volunteers
- 534 people
- Sponsor
- Hoffmann-La Roche
Solid Tumor
Phase II Study of AB-106 to Treat Patients With Solid Tumors With NTRK Gene Fusion
AB-106 will be administered once a day. Each treatment cycle is defined as 21 days of continuous medication. Dosing will continue until any of the following conditions are met: disease progression, intolerable drug-related…
- Trial name
- NCT04617054
- Testing
- AB-106
- Where
- China
- Volunteers
- 14 people
- Sponsor
- Nuvation Bio Inc.
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects
This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate Food effect and Relative bioavailability of VC004 Capsules in healthy subjects
- Trial name
- NCT06529445
- Testing
- High Dose VC004 Capsules, Median Dose VC004 Capsules, Low Dose VC004 Capsules
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
Solid Tumors Harboring NTRK Fusion
Study to Compare How the Body Absorbs, Distributes and Excretes the Drug Selitrectinib (BAY2731954) Given as Two Different Tablet Formulations or as Liquid Formulations Including the Effect of Food on the Absorption, Distribution or Excretion of the Different Formulations in Healthy Participants
In this study, the researchers will compare 2 new tablet forms of BAY2731954 with liquid oral forms of BAY2731954. A maximum of 61 healthy volunteers aged 18 to 55 will be asked to participate. The study will have 2 parts.
- Trial name
- NCT04771390
- Testing
- Selitrectinib (BAY2731954) Adult tablet, Selitrectinib (BAY2731954) Pediatric tablet, Selitrectinib (BAY2731954) Oral solution
- Where
- 2 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Bayer
Solid Tumor
Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors
This study will determine the safety and maximum tolerated dose of ONO-7579 in patients with advanced solid tumors, and evaluate efficacy of ONO-7579 in patients with advanced solid tumors harboring NTRK gene fusions.
- Trial name
- ONTRK (NCT03182257)
- Testing
- ONO-7579
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 1 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Solid Tumors Harboring NTRK Fusion
A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer
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).
- Trial name
- NCT03215511
- Testing
- Selitrectinib (BAY2731954)
- Where
- 29 sites in United States, Australia and 8 more
- Volunteers
- 81 people
- Sponsor
- Bayer