Clinical trials: ROS1 Gene Rearrangement
Advanced Solid Tumor, Metastatic Solid Tumor
A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors
This is a Phase 1 study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on certain drug transporters in patients with advanced cancer.
- Trial name
- NCT05828303
- Testing
- TPX-0005, Metformin Hydrochloride, Digoxin
- Where
- 33 sites in United States, Australia and 4 more
- Sponsor
- Turning Point Therapeutics, Inc.
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
Carcinoma, Non-Small-Cell Lung
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC).
- Trial name
- NCT04603807
- Testing
- Entrectinib, Crizotinib
- Where
- 61 sites in Brazil, China and 16 more
- Volunteers
- 217 people
- Sponsor
- Hoffmann-La Roche
Locally Advanced Solid Tumors, Metastatic Solid Tumors
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult…
- Trial name
- TRIDENT-1 (NCT03093116)
- Testing
- Oral repotrectinib (TPX-0005)
- Where
- 165 sites in United States, Australia and 17 more
- Volunteers
- 500 people
- Sponsor
- Turning Point Therapeutics, Inc.
Protein Kinase Inhibitors, Other Protocol Specified Criteria
Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced/metastatic solid tumors .
- Conditions
- Protein Kinase Inhibitors, Other Protocol Specified Criteria, Lung Neoplasms, Brain Neoplasms
- Trial name
- JYP0322 (NCT06128148)
- Testing
- JYP0322 50 mg qd, JYP0322 100 mg qd, JYP0322 200 mg qd
- Where
- China
- Volunteers
- 101 people
- Sponsor
- Guangzhou JOYO Pharma Co., Ltd
Non-Small Cell Lung Cancer ALK-positive, Non-Small Cell Lung Cancer c-Met Dependent
A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors.
- Conditions
- Non-Small Cell Lung Cancer ALK-positive, Non-Small Cell Lung Cancer c-Met Dependent, Non-Small Cell Lung Cancer ROS Marker Positive, Systemic Anaplastic Large-Cell Lymphoma
- Trial name
- PROFILE 1001 (NCT00585195)
- Testing
- PF-02341066, Rifampin, Itraconazole
- Where
- 29 sites in United States, Australia and 2 more
- Volunteers
- 596 people
- Sponsor
- Pfizer
Locally Advanced Solid Tumor, Metastatic Solid Tumor
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of zidesamtinib (NVL-520), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with…
- Trial name
- NCT05118789
- Testing
- Zidesamtinib (NVL-520)
- Where
- 63 sites in United States, Australia and 12 more
- Volunteers
- 359 people
- Sponsor
- Nuvalent Inc.
Solid Tumors, CNS Tumors
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain…
- Trial name
- STARTRK-NG (NCT02650401)
- Testing
- Entrectinib
- Where
- 26 sites in United States, Canada and 7 more
- Volunteers
- 69 people
- Sponsor
- Hoffmann-La Roche
ROS1 Rearrangement Non-small Cell Lung Cancer, ALK Rearrangement Non-small Cell Lung Cancer
A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer
This is a multicenter, open-label, dose escalation, and expansion human clinical study to observe the safety, tolerability, pharmacokinetics, and pharmacodynamics of XZP-3621 in single and multiple oral administrations in…
- Trial name
- NCT05055232
- Testing
- XZP-3621
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Xuanzhu Biopharmaceutical 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
NSCLC, Crizotinib
Descriptive Observational Study ALK-2016-CPHG
Descriptive Observational Study. Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals
- Conditions
- NSCLC, Crizotinib, ALK Gene Rearrangement or ROS1 Gene Rearrangement
- Trial name
- ALK2016CPHG (NCT03718117)
- Where
- 26 sites in France
- Volunteers
- 73 people
- Sponsor
- Pfizer
Lung Cancer, ROS1 Gene Rearrangement
X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement
To assess treatment effectiveness and safety of oral X-396 capsule (Ensartinib) administered to Chinese patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a c-ROS Oncogene (ROS1)…
- Trial name
- NCT03608007
- Testing
- X-396 Capsule
- Where
- China
- Volunteers
- 69 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.