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Clinical trials for Entrectinib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    17 result(s) found for: Entrectinib. Displaying page 1 of 1.
    EudraCT Number: 2019-001155-39 Sponsor Protocol Number: CO40778 Start Date*: 2019-11-22
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE 1/2, OPEN-LABEL, DOSE-ESCALATION AND EXPANSION STUDY OF ENTRECTINIB (RXDX-101) IN PEDIATRICS WITH LOCALLY ADVANCED OR METASTATIC SOLID OR PRIMARY CNS TUMORS AND/OR WHO HAVE NO SATISFACTORY ...
    Medical condition: Solid tumors and primary central nervous system (CNS) tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-000783-15 Sponsor Protocol Number: GP41341 Start Date*: 2019-05-07
    Sponsor Name:Genentech, Inc.
    Full Title: A RANDOMIZED, OPEN-LABEL, TWO PART STUDY TO EXPLORE THE PERFORMANCE OF ENTRECTINIB PROTOTYPE MINI-TABLET FORMULATIONS AND THE EFFECT OF DRUG SUBSTANCE PARTICLE SIZE ON ENTRECTINIB BIOAVAILABILITY I...
    Medical condition: non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), salivary gland cancers, papillary thyroid cancer, melanoma, and sarcomas
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10023774 Large cell lung cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061934 Salivary gland cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033701 Papillary thyroid cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10053571 Melanoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10039491 Sarcoma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-003859-11 Sponsor Protocol Number: MO41552 Start Date*: 2022-02-03
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: RANDOMIZED, OPEN LABEL, MULTICENTER, PHASE III STUDY OF ENTRECTINIB VERSUS CRIZOTINIB IN PATIENTS WITH LOCALLYADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER HARBORING ROS1 GENE REARRANGEMENTS WI...
    Medical condition: Non-small cell lung cancer with ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene rearrangements
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) DE (Trial now transitioned) GR (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) SK (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned) HR (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003385-84 Sponsor Protocol Number: GO40782(RXDX-101-02) Start Date*: 2016-03-15
    Sponsor Name:F. Hoffman-La Roche Ltf
    Full Title: AN OPEN-LABEL, MULTICENTER, GLOBAL PHASE 2 BASKET STUDY OF ENTRECTINIB FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS THAT HARBOR NTRK1/2/3, ROS1, OR ALK GENE REARRA...
    Medical condition: Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004942-14 Sponsor Protocol Number: IJB-LOB-2019 Start Date*: Information not available in EudraCT
    Sponsor Name:Institut Jules Bordet
    Full Title: Neoadjuvant study of targeting ROS1 in combination with endocrine therapy in invAsive Lobular carcINoma of the breast
    Medical condition: ER-positive/HER2-negative invasive lobular carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073096 Invasive lobular breast carcinoma PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-004149-19 Sponsor Protocol Number: BO42777 Start Date*: 2022-05-24
    Sponsor Name:F. Hoffmann La Roche Ltd.
    Full Title: A PHASE I-III, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF PATIENTS SELECTED ACCORDING TO BIOMARKER STATUS, WITH LOCALLY ADVANCED, UNRESECTABLE, STAGE I...
    Medical condition: Non-Small Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004864 10084713 Tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) DE (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003040-20 Sponsor Protocol Number: MX39795 Start Date*: 2018-06-20
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A phase II, randomized, active-controlled, multi-center study comparing the efficacy and safety of targeted therapy or cancer immunotherapy guided by genomic profiling versus platinum-based chemoth...
    Medical condition: Cancer of Unknown Primary Site
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10032248 Other malignant neoplasm of unspecified site LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Completed) EE (Completed) IE (Completed) DE (Completed) CZ (Completed) FI (Completed) LV (Completed) HU (Completed) PL (Completed) FR (Completed) ES (Ongoing) BG (Completed) PT (Completed) HR (Completed) NO (Completed) NL (Completed) DK (Completed) CY (Prematurely Ended) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2020-001847-16 Sponsor Protocol Number: BO41932 Start Date*: 2021-03-18
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL
    Medical condition: Locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are TMB-high as identified by a validated NGS assay
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065147 Malignant solid tumor LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065252 Solid tumor LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) NL (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003616-13 Sponsor Protocol Number: TPX-0005-01 Start Date*: 2020-05-12
    Sponsor Name:Turning Point Therapeutics, Inc.
    Full Title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ...
    Medical condition: advanced solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) DE (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) HU (Trial now transitioned) DK (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004466-19 Sponsor Protocol Number: IFCT-2003 Start Date*: 2021-01-07
    Sponsor Name:IFCT
    Full Title: A phase II single-group assignment, multicenter study of efficacy and safety of lorlatinib monotherapy after failure of first-line tyrosine kinase inhibitor in patients with advanced ROS1-positive ...
    Medical condition: advanced ROS1-positive non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000076-28 Sponsor Protocol Number: BO29554 Start Date*: 2017-08-25
    Sponsor Name:Roche Farma S.A (Soc.Unipersonal) que realiza el ensayo
    Full Title: A PHASE II/III MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TARGETED THERAPIES AS TREATMENTS FOR PATIENTS WITH ADVANCED OR METASTATIC NON SMALL CELL LUNG CANCER (NSCLC) HARBORIN...
    Medical condition: Advanced or metastatic Non-small cell lung cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Trial now transitioned) BE (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001326-15 Sponsor Protocol Number: RXDX-101-01 Start Date*: 2014-10-15
    Sponsor Name:Ignyta Inc.
    Full Title: A Phase 1/2a, Multicenter, Open-Label Study of Oral RXDX-101 in Adult Patients with Locally Advanced or Metastatic Cancer Confirmed to be Positive for TrkA, TrkB, TrkC, ROS1, or ALK Molecular Alter...
    Medical condition: Locally advanced or metastatic solid tumors
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10065252 Solid tumor LLT
    17.0 100000004864 10065143 Malignant solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-002477-26 Sponsor Protocol Number: NVL-520-01 Start Date*: 2021-11-26
    Sponsor Name:Nuvalent, Inc.
    Full Title: A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)
    Medical condition: Advanced Non-Small Cell Lung Cancer (NSCLC)and Other Solid Tumors with ROS1+ rearrangement
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) NL (Ongoing) DE (Ongoing) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002190-21 Sponsor Protocol Number: MAR-BAS-18-005 Start Date*: 2020-07-08
    Sponsor Name:Fondazione per la Medicina Personalizzata
    Full Title: The ROME trial from histology to target: the road to personalize target therapy and immunotherapy
    Medical condition: Patients with progressive disease (recurrent and/or metastatic) of breast cancer, metastatic gastro-intestinal tumors, non small cell lung cancer (NSCLC) or others. Patients should have completed a...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066275 Comedocarcinoma of breast LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007351 Carcinoma gastrointestinal LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071533 Lung squamous cell carcinoma metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003091-14 Sponsor Protocol Number: AB-106-G208 Start Date*: 2022-06-09
    Sponsor Name:AnHeart Therapeutics Inc
    Full Title: A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors
    Medical condition: Non Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029515 Non-small cell lung cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003296-19 Sponsor Protocol Number: AFM24-101 Start Date*: 2020-03-27
    Sponsor Name:Affimed GmbH
    Full Title: A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients with Advanced Solid Cancers
    Medical condition: Advanced solid malignancies in patients whose disease has progressed after treatment with previous anticancer therapies.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004246-20 Sponsor Protocol Number: 20810 Start Date*: 2018-03-06
    Sponsor Name:Bayer Consumer Care AG
    Full Title: A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers Formerly: A Phase 1/2 Study of the TRK Inhibitor LOXO-1...
    Medical condition: NTRK fusion cancers previously treated with a TRK inhibitor
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049516 Malignant tumor LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007958 Central nervous system neoplasm PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) FR (Completed) DE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) IE (Completed) IT (Prematurely Ended) BE (Completed)
    Trial results: View results
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