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39 Diseases | | 1 Product |
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21 Trials |  |
390 News |  |
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- | Biomarker, New P2 trial: NRG-LU003: Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Nov 13, 2018
P2, N=660, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- | Biomarker, Enrollment change, BRCA Biomarker, PARP Biomarker, Metastases: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (clinicaltrials.gov) - Nov 5, 2018
P2, N=1000, Recruiting, Sponsor: National Cancer Institute (NCI)
N=1500 --> 1000
- | Ensacove (ensartinib) / Xcovery, Imfinzi (durvalumab) / AstraZeneca
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer (clinicaltrials.gov) - Aug 21, 2018
P1/2, N=2, Completed, Sponsor: Ludwig Institute for Cancer Research
N=1500 --> 1000 Active, not recruiting --> Completed | N=32 --> 2 | Trial completion date: Dec 2023 --> Aug 2017 | Trial primary completion date: May 2019 --> Aug 2017
- | Ensacove (ensartinib) / Xcovery
New P2 trial, Metastases: X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement (clinicaltrials.gov) - Jul 31, 2018
P2, N=69, Recruiting, Sponsor: Betta Pharmaceuticals Co.,Ltd.
- | Ensacove (ensartinib) / Xcovery
Trial completion date: A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers. (clinicaltrials.gov) - Jul 19, 2018
P1, N=24, Enrolling by invitation, Sponsor: Betta Pharmaceuticals Co.,Ltd.
Active, not recruiting --> Completed | N=32 --> 2 | Trial completion date: Dec 2023 --> Aug 2017 | Trial primary completion date: May 2019 --> Aug 2017 Trial completion date: Apr 2018 --> Jul 2018
- | Ensacove (ensartinib) / Xcovery
Trial completion date, Trial primary completion date: Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK (clinicaltrials.gov) - Jul 18, 2018
P1, N=24, Recruiting, Sponsor: Betta Pharmaceuticals Co.,Ltd.
Trial completion date: Apr 2018 --> Jul 2018 Trial completion date: Feb 2018 --> Jun 2019 | Trial primary completion date: Nov 2017 --> Jul 2018
- | Biomarker, New P2 trial, IO biomarker, Metastases: TRUMP: Phase II Umbrella Study Directed by Next Generation Sequencing (clinicaltrials.gov) - Jul 2, 2018
P2, N=400, Not yet recruiting, Sponsor: Guangdong Association of Clinical Trials
- | Ensacove (ensartinib) / Xcovery
New P1 trial: Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers (clinicaltrials.gov) - Jun 3, 2018
P1, N=96, Not yet recruiting, Sponsor: Betta Pharmaceuticals Co.,Ltd.
- | Ensacove (ensartinib) / Xcovery
New P1 trial: A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers. (clinicaltrials.gov) - Apr 26, 2018
P1, N=24, Enrolling by invitation, Sponsor: Betta Pharmaceuticals Co.,Ltd.
- | Biomarker, Trial completion date, Trial primary completion date, BRCA Biomarker, PARP Biomarker, Metastases: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (clinicaltrials.gov) - Apr 12, 2018
P2, N=1500, Recruiting, Sponsor: National Cancer Institute (NCI)
Trial completion date: Feb 2018 --> Jun 2019 | Trial primary completion date: Nov 2017 --> Jul 2018 Trial completion date: Dec 2021 --> Sep 2027 | Trial primary completion date: Dec 2021 --> Sep 2027
- | Ensacove (ensartinib) / Xcovery
Biomarker, Trial completion date, Trial primary completion date, Metastases: Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial) (clinicaltrials.gov) - Apr 10, 2018
P2, N=98, Recruiting, Sponsor: National Cancer Institute (NCI)
Trial completion date: Dec 2021 --> Sep 2027 | Trial primary completion date: Dec 2021 --> Sep 2027 Trial completion date: Mar 2021 --> Sep 2024 | Trial primary completion date: Mar 2021 --> Sep 2024
- || Ensacove (ensartinib) / Xcovery
Trial completion date, Trial primary completion date, Metastases: Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Mar 7, 2018
P1/2, N=190, Recruiting, Sponsor: Xcovery Holding Company, LLC
Trial completion date: Mar 2021 --> Sep 2024 | Trial primary completion date: Mar 2021 --> Sep 2024 Trial completion date: Nov 2020 --> Nov 2021 | Trial primary completion date: Nov 2019 --> Nov 2020
- | Ensacove (ensartinib) / Xcovery, Imfinzi (durvalumab) / AstraZeneca
Enrollment closed: Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer (clinicaltrials.gov) - Feb 23, 2018
P1/2, N=32, Active, not recruiting, Sponsor: Ludwig Institute for Cancer Research
Trial completion date: Nov 2020 --> Nov 2021 | Trial primary completion date: Nov 2019 --> Nov 2020 Recruiting --> Active, not recruiting
- | Ensacove (ensartinib) / Xcovery
New P2 trial: Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov) - Feb 5, 2018
P2, N=18, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
- | Ensacove (ensartinib) / Xcovery
Enrollment open, Trial primary completion date: X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib (clinicaltrials.gov) - Dec 21, 2017
P2, N=152, Recruiting, Sponsor: Betta Pharmaceuticals Co.,Ltd.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Trial primary completion date: Jan 2019 --> Sep 2018
- | Zykadia (ceritinib) / Novartis
Review, Journal: The accelerated path of ceritinib: Translating pre-clinical development into clinical efficacy. (Pubmed Central) - Aug 10, 2017
The discovery of anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancer (NSCLC) in 2007 led to the development and subsequent approval of the ALK inhibitor crizotinib in 2011...There is now a next generation of ALK inhibitors, including two that have been approved-ceritinib and alectinib-and others that are in development-brigatinib, lorlatinib and X-396...Selective gastrointestinal toxicity of ceritinib, such as diarrhea, nausea and vomiting is generally manageable with prophylactic medication and prompt dose reduction or interruption. Future progress in treating ALK+ NSCLC will focus on determining the optimal sequencing of therapies and strategies to overcome acquired resistance, an ongoing challenge in treating ALK-mutation-driven tumors.
- | Biomarker, Enrollment open, BRCA Biomarker, PARP Biomarker, Metastases: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (clinicaltrials.gov) - Jul 28, 2017
P2, N=1500, Recruiting, Sponsor: National Cancer Institute (NCI)
Future progress in treating ALK+ NSCLC will focus on determining the optimal sequencing of therapies and strategies to overcome acquired resistance, an ongoing challenge in treating ALK-mutation-driven tumors. Not yet recruiting --> Recruiting
- | Ensacove (ensartinib) / Xcovery
Biomarker, Enrollment open, Metastases: Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial) (clinicaltrials.gov) - Jul 27, 2017
P2, N=98, Recruiting, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Biomarker, BRCA Biomarker, PARP Biomarker, Metastases: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (clinicaltrials.gov) - Jul 19, 2017
P2, N=1500, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting N=568 --> 1500
- | Ensacove (ensartinib) / Xcovery
New P2 trial: X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib (clinicaltrials.gov) - Jul 11, 2017
P2, N=144, Not yet recruiting, Sponsor: Betta Pharmaceuticals Co.,Ltd.
- | Ensacove (ensartinib) / Xcovery
Biomarker, New P2 trial, Metastases: Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial) (clinicaltrials.gov) - Jul 11, 2017
P2, N=98, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- | Biomarker, New P2 trial, BRCA Biomarker, PARP Biomarker, Metastases: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (clinicaltrials.gov) - May 15, 2017
P2, N=568, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- | Ensacove (ensartinib) / Xcovery
Enrollment open: Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK (clinicaltrials.gov) - Apr 27, 2017
P1, N=24, Recruiting, Sponsor: Betta Pharmaceuticals Co.,Ltd.
N=568 --> 1500 Not yet recruiting --> Recruiting
- | Ensacove (ensartinib) / Xcovery, Imfinzi (durvalumab) / AstraZeneca
Enrollment open, Trial initiation date: Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer (clinicaltrials.gov) - Mar 5, 2017
P1/2, N=32, Recruiting, Sponsor: Ludwig Institute for Cancer Research
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Dec 2016 --> Mar 2017
- Ensacove (ensartinib) / Xcovery
New P1 trial: Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK (clinicaltrials.gov) - Nov 8, 2016
P1, N=24, Not yet recruiting, Sponsor: Betta Pharmaceuticals Co.,Ltd.
- | Ensacove (ensartinib) / Xcovery, Imfinzi (durvalumab) / AstraZeneca
New P1/2 trial: Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer (clinicaltrials.gov) - Sep 13, 2016
P1/2, N=32, Not yet recruiting, Sponsor: Ludwig Institute for Cancer Research
- ||| Ensacove (ensartinib) / Xcovery
Enrollment change, Trial primary completion date, Metastases: Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Aug 10, 2016
P1/2, N=150, Recruiting, Sponsor: Xcovery Holding Company, LLC
Not yet recruiting --> Recruiting | Initiation date: Dec 2016 --> Mar 2017 N=100 --> 150 | Trial primary completion date: Dec 2016 --> Nov 2019
- |||||| Ensacove (ensartinib) / Xcovery
Enrollment open: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov) - Jul 1, 2016
P3, N=402, Recruiting, Sponsor: Xcovery Holding Company, LLC
N=100 --> 150 | Trial primary completion date: Dec 2016 --> Nov 2019 Not yet recruiting --> Recruiting
- |||||||||| Ensacove (ensartinib) / Xcovery
New P3 trial: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov) - May 10, 2016
P3, N=402, Not yet recruiting, Sponsor: Xcovery Holding Company, LLC
- || Ensacove (ensartinib) / Xcovery
Trial primary completion date, Metastases: Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Feb 3, 2016
P1/2, N=100, Recruiting, Sponsor: Xcovery Holding Company, LLC
Not yet recruiting --> Recruiting Trial primary completion date: Feb 2016 --> Dec 2016
- || Ensacove (ensartinib) / Xcovery
Phase classification, Trial primary completion date, Metastases: Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jan 15, 2015
P1/2, N=100, Recruiting, Sponsor: Xcovery Holding Company, LLC
Trial primary completion date: Feb 2016 --> Dec 2016 Phase classification: P1 --> P1/2 | Trial primary completion date: Feb 2015 --> Feb 2016
- || Ensacove (ensartinib) / Xcovery
Enrollment change, Trial primary completion date, Metastases: Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Aug 22, 2014
P1, N=100, Recruiting, Sponsor: Xcovery Holding Company, LLC
Phase classification: P1 --> P1/2 | Trial primary completion date: Feb 2015 --> Feb 2016 N=60 --> 100 | Trial primary completion date: Dec 2013 --> Feb 2015
- ||| Ensacove (ensartinib) / Xcovery
New P1 trial, Metastases: Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jun 19, 2012
P1, N=60, Recruiting, Sponsor: Xcovery Holding Company, LLC