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1 Disease |  |
21 Trials |
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21 Trials |  |
381 News |  |
| «123456» |
- Large-scale study of NTRK fusions in Chinese solid tumors and using next generation sequencing: A multicenter study (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_224;
The NTRK gene fusions more commonly occurred in NSCLC (0.3%), CRC (0.4%) and BC (0.2%), and may occur without other targetable alterations such as EGFR, ALK, ROS1. The clinical evidence for responsiveness of NTRK fusions driven solid tumors provides an opportunity to personalize treatments and improve clinical outcomes for patients (pts).
- ensartinib (X-396) / Xcovery, Xalkori (crizotinib) / Pfizer
Longitudinal circulating tumor DNA (ctDNA) analysis predicts response and reveals the resistance mechanisms of ensartinib in ALK+ NSCLC patients (pts) progressed on crizotinib: Updated analysis of a phase II clinical trial (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_2203;
P2
Longitudinal ctDNA analysis could be a powerful tool in predicting treatment outcomes and revealing resistant mechanisms of ensartinib. We observed G1269A, G1202R and E1210K as the major resistant mutations to ensartinib.
- | Ensacove (ensartinib) / Betta Pharma
Biomarker, 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) - May 5, 2020
P2, N=98, Recruiting, Sponsor: National Cancer Institute (NCI)
We observed G1269A, G1202R and E1210K as the major resistant mutations to ensartinib. Trial primary completion date: Dec 2025 --> Sep 2024
- | Ensacove (ensartinib) / Betta Pharma
Biomarker, Enrollment open, 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) - May 3, 2020
P2, N=98, Recruiting, Sponsor: National Cancer Institute (NCI)
Trial primary completion date: Dec 2025 --> Sep 2024 Suspended --> Recruiting | Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2025
- ensartinib (X-396) / Xcovery, Xalkori (crizotinib) / Pfizer
[VIRTUAL] A phase I, dose-escalation and expansion study of TQ-B3139, a novel ALK TKI, in Chinese ALK or ROS1 positive advanced non-small cell lung cancer (NSCLC). (Poster Board 351) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2438;
P1
RP2D was established at 600mg bid. A randomized phase III trial of TQ-B3139 versus Crizotinib in advanced ALK-TKI naïve NSCLC patients is underway.
- | Journal: Rapid advances in research on and development of anticancer drugs in China. (Pubmed Central) - Apr 3, 2020
There are unprecedented opportunities for development of innovative drugs in China. In the future, innovative drug development in China is poised to shift from "me too" or "me better" drugs to "first-in-class" or "best-in-class" drugs.
- || ensartinib (X-396) / Xcovery
PK/PD data, Journal: Ensartinib (X-396) Effectively Modulates Pharmacokinetic Resistance Mediated by ABCB1 and ABCG2 Drug Efflux Transporters and CYP3A4 Biotransformation Enzyme. (Pubmed Central) - Apr 2, 2020
In conclusion, ensartinib may perpetrate clinically relevant pharmacokinetic DDIs and modulate ABCB1-, ABCG2-, and CYP3A4-mediated MDR. The in vitro findings presented here will provide a valuable foundation for future in vivo investigations.
- | 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) - Apr 1, 2020
P2, N=1500, Recruiting, Sponsor: National Cancer Institute (NCI)
The in vitro findings presented here will provide a valuable foundation for future in vivo investigations. N=1000 --> 1500
- || ensartinib (X-396) / Xcovery
Thanks...1584 x 396 px possible?? (Twitter) - Mar 30, 2020
- || ensartinib (X-396) / Xcovery
Clinical, Journal: Ensartinib (X-396) a novel drug for anaplastic lymphoma kinasepositive non-small cell lung cancer patients: we need smart trials to avoid wasting good bullets. (Pubmed Central) - Mar 29, 2020
N=1000 --> 1500 No abstract available
- || ensartinib (X-396) / Xcovery
Clinical, Journal: Ensartinib (X-396): what does it add for patients with ALK-rearranged NSCLC. (Pubmed Central) - Mar 29, 2020
No abstract available No abstract available
- || ensartinib (X-396) / Xcovery
Clinical, Journal: Circulating tumor (ct) DNA analysis to monitor response and resistance to ensartinib in patients (pts) with ALK+ non-small cell lung cancer (NSCLC). (Pubmed Central) - Mar 7, 2020
No abstract available No abstract available
- |||||| ensartinib (X-396) / Xcovery
. @HornLeora from @VUMC_Cancer presenting at @IASLC #TTLC20 on Alk-inhibitor ensartinib #LCSM (Twitter) - Feb 21, 2020
- |||||| ensartinib (X-396) / Xcovery
Clinical: Dr. Leora Horn, @HornLeora, presenting systemic and CNS activity of ensartinib for patients with ALK rearrangements. We have been happy to partner with these trials with this active agent and importantscience. @ChilesResearch @IASLC #TTLC20 (Twitter) - Feb 21, 2020
- |||||| ensartinib (X-396) / Xcovery
Clinical: Ensartinib ORR by prior ALK treatment presented by @HornLeora @IASLC. Has cns activity. Rash management key and unique from other ALKi. More data time come from ALK Master Protocol (Twitter) - Feb 21, 2020
- ensartinib (X-396) / Xcovery
Ensartinib (STARLIGHT BALLROOM) - Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_239;
- | Ensacove (ensartinib) / Betta Pharma
Biomarker, Trial suspension, 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) - Feb 10, 2020
P2, N=98, Suspended, Sponsor: National Cancer Institute (NCI)
No abstract available Recruiting --> Suspended
- | Biomarker, Enrollment open, IO biomarker, Metastases: TRUMP: Phase II Umbrella Study Directed by Next Generation Sequencing (clinicaltrials.gov) - Feb 10, 2020
P2, N=400, Recruiting, Sponsor: Guangdong Association of Clinical Trials
Recruiting --> Suspended Not yet recruiting --> Recruiting
- | Ensacove (ensartinib) / Xcovery
Enrollment closed: Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov) - Jan 23, 2020
P2, N=18, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||| Ensacove (ensartinib) / Xcovery
Trial completion date, Trial primary completion date: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov) - Jan 13, 2020
P3, N=290, Active, not recruiting, Sponsor: Xcovery Holding Company, LLC
Recruiting --> Active, not recruiting Trial completion date: Apr 2020 --> Dec 2020 | Trial primary completion date: Nov 2018 --> Dec 2020
- || Ensacove (ensartinib) / Xcovery
Trial completion date, Trial primary completion date, Metastases: X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement (clinicaltrials.gov) - Jan 8, 2020
P2, N=69, Recruiting, Sponsor: Betta Pharmaceuticals Co., Ltd.
Trial completion date: Apr 2020 --> Dec 2020 | Trial primary completion date: Nov 2018 --> Dec 2020 Trial completion date: May 2020 --> Sep 2020 | Trial primary completion date: Dec 2019 --> Mar 2020
- | Ensacove (ensartinib) / Xcovery
Trial completion date, Trial primary completion date: Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov) - Jan 6, 2020
P2, N=18, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: May 2020 --> Sep 2020 | Trial primary completion date: Dec 2019 --> Mar 2020 Trial completion date: Jan 2020 --> Jan 2021 | Trial primary completion date: Jan 2020 --> Jan 2021
- || Review, Journal: New generation anaplastic lymphoma kinase inhibitors. (Pubmed Central) - Dec 22, 2019
Some of them were approved after the failure of crizotinib (ceritinib, alectinib, brigatinib and lorlatinib) and in first line setting (ceritinib, alectinib and brigatinib) while others are still under evaluation for TKI-naive patients such as lorlatinib, ensartinib and entrectinib. In this review we will discuss the most recent results of new TKIs in order to describe a fast growing therapeutic landscape in this setting.
- ||| ensartinib (X-396) / Xcovery
Clinical: Nice to be compared in champions league slide ⚽️ to Juventus being from Torino myself and the development lead of #ensartinib 🇮🇹😉... agree on tough ground for comparisons without H2H trials. Open label skews INV PFS assessments. @JackWestMD @DrSanjayPopat (Twitter) - Nov 26, 2019
- || ensartinib (X-396) / Xcovery
Clinical, P1/2 data, Journal: Ensartinib (X-396) in ALK-positive Non-Small Cell Lung Cancer: Results from a First-in-Human Phase I/II, Multicenter Study. (Pubmed Central) - Nov 22, 2019
In this review we will discuss the most recent results of new TKIs in order to describe a fast growing therapeutic landscape in this setting. Ensartinib was active and generally well tolerated in patients with ALK-positive NSCLC.
- |||||| Ensacove (ensartinib) / Xcovery
New trial: Expanded Access to Ensartinib for Participants With ALK+ NSCLC (clinicaltrials.gov) - Nov 4, 2019
P, N=0, Available, Sponsor: Xcovery Holding Company, LLC
- ||||| ensartinib (X-396) / Xcovery
In this new article, Dr. Horn and colleagues evaluate the utility of analyzing ctDNA as a function of response to ensartinib, a potent second-generation ALK TKI. #LCSM #ALK #LungCancer @HwakeleeMD @christine_lovly @VUMC_Cancer Read the full article --> https://t.co/bBRUwWRpdn (Twitter) - Nov 1, 2019
- ||| Ensacove (ensartinib) / Xcovery
Enrollment closed, Enrollment change, Metastases: Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Oct 30, 2019
P1/2, N=131, Active, not recruiting, Sponsor: Xcovery Holding Company, LLC
Ensartinib was active and generally well tolerated in patients with ALK-positive NSCLC. Recruiting --> Active, not recruiting | N=190 --> 131
- | Alecensa (alectinib) / Roche
Clinical, Journal: Chinese perspectives on clinical efficacy and safety of alectinib in patients with ALK-positive advanced non-small cell lung cancer. (Pubmed Central) - Oct 17, 2019
Alectinib offers greater potency with greater specificity as well as a better toxicity profile than many other TKIs that are currently available. Here, we review the role of ALK as a therapeutic target in NSCLC, the testing methods for identifying ALK-rearranged NSCLC, and the various TKIs currently being used or explored for treatment in this setting, with a focus on alectinib from a Chinese perspective.
- ||||| ensartinib (X-396) / Xcovery
Clinical: Great to see this phase 2 data on Ensartinib in criz-refractory #ALK positive #NSCLC Intersting to see good CNS activity and efficacy by genotype including some unexpected responses (N2/6) to G1202R but not L1196M https://t.co/AZqgCQ6pFP (Twitter) - Oct 17, 2019
- | Journal: ALK Fusion Partners Impact Response to ALK Inhibition: Differential Effects on Sensitivity, Cellular Phenotypes, and Biochemical Properties. (Pubmed Central) - Sep 20, 2019
This study shows that the 5' ALK fusion partner influences ALK TKI drug sensitivity. As many other kinase fusions are found in numerous cancers, often with overlapping fusion partners, these studies have ramifications for other kinase-driven malignancies.
- ||| ensartinib (X-396) / Xcovery
More data on Ensartinib. A rash can be good news... #lcsm #WCLC19 (Twitter) - Sep 9, 2019
- ||||| ensartinib (X-396) / Xcovery
Just Out 📢our Awesome🙌 #OncoAlert 🚨 Colleague @PatelOncology presenting his groups work "Post Ensartinib outcomes in refractory ALK rearranged #NSCLC " during @IASLC #WCLC19 #LCSM (Twitter) - Sep 8, 2019
- |||| ensartinib (X-396) / Xcovery
Clinical: Good to see some updates that too positive one on "Ensartinib" for @ALKLungCancer ...Seems Ensartinib will be another good option for patients. Many thanks @PatelOncology 🙏 #LCSM #WCLC19 @ns_chd @drnirmalraut @VanitaNoronha @SirohiBhawna @PSKulkarni (Twitter) - Sep 8, 2019
- |||||| ensartinib (X-396) / Xcovery
Clinical: Nice poster by @PatelOncology and team: no new somatic mutations in ALK+ patients treated by ensartinib. Some patients respond to 2nd gen ALK tki even after ensartinib. Optimal sequence still TBD. (Twitter) - Sep 8, 2019
- | Ensacove (ensartinib) / Xcovery
Trial completion date, Trial primary completion date: Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK (clinicaltrials.gov) - Jul 24, 2019
P1, N=24, Recruiting, Sponsor: Betta Pharmaceuticals Co., Ltd.
As many other kinase fusions are found in numerous cancers, often with overlapping fusion partners, these studies have ramifications for other kinase-driven malignancies. Trial completion date: Jun 2019 --> Dec 2020 | Trial primary completion date: Jul 2018 --> Dec 2019
- | Ensacove (ensartinib) / Xcovery
Trial completion: Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers (clinicaltrials.gov) - Jul 24, 2019
P1, N=74, Completed, Sponsor: Betta Pharmaceuticals Co., Ltd.
Trial completion date: Jun 2019 --> Dec 2020 | Trial primary completion date: Jul 2018 --> Dec 2019 Not yet recruiting --> Completed
- | Ensacove (ensartinib) / Xcovery
Trial completion, Trial primary completion date: A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers. (clinicaltrials.gov) - Jul 24, 2019
P1, N=24, Completed, Sponsor: Betta Pharmaceuticals Co., Ltd.
Not yet recruiting --> Completed Enrolling by invitation --> Completed | Trial primary completion date: Apr 2018 --> Aug 2018
- ||||| ensartinib (X-396) / Xcovery
#ASCO19 #lcsm #OncoAlert @HornLeora about ensartinib overcome resistance after second generation ALK TKIs (Twitter) - Jun 1, 2019
- ||||| Clinical: @HornLeora opening her review on ALK lung cancer with a case. If 2011, she would have given criz, if 2014 certinib, if 2017 alectinib, but now she considers brigatinib as well and looks forward to ensartinib and lorlatinib data. So much progress! #ASCO19 #LCSM (Twitter) - Jun 1, 2019
- | Biomarker, Enrollment open: NRG-LU003: Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Apr 16, 2019
P2, N=660, Recruiting, Sponsor: National Cancer Institute (NCI)
Enrolling by invitation --> Completed | Trial primary completion date: Apr 2018 --> Aug 2018 Not yet recruiting --> Recruiting
- |||||| ensartinib (X-396) / Xcovery
Clinical: #ELCC19 Lack of ctDNA ALK noted in patients with lower tumor burden but those patients still responded to ensartinib @HornLeora #OncoAlert (Twitter) - Apr 10, 2019
- ||||| ensartinib (X-396) / Xcovery
Clinical, Next-Generation Sequencing: CtDNA for monitoring treatment efficacy on ensartinib by Lora Horn. Concordance tissue plasma 90%. 9% double negative also respond on ensartinib. NGS is not enough for catching all ALK Positive? CtDNA on treatment for monitoring #ELCC19 (Twitter) - Apr 10, 2019
- ||||| ensartinib (X-396) / Xcovery
#ELCC19 Ensartinib data presented by @HornLeora in #ALK #NSCLC with ctDNA serial analysis to monitor response and resistance #OncoAlert #LCSM (Twitter) - Apr 10, 2019
- ||||| Ensacove (ensartinib) / Xcovery
Enrollment closed, Trial primary completion date: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov) - Jan 17, 2019
P3, N=293, Active, not recruiting, Sponsor: Xcovery Holding Company, LLC
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2020 --> Nov 2018
- || Ensacove (ensartinib) / Xcovery
New P1 trial: The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human (clinicaltrials.gov) - Jan 15, 2019
P1, N=6, Recruiting, Sponsor: Betta Pharmaceuticals Co.,Ltd.
- | Ensacove (ensartinib) / Xcovery
New P2 trial: X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases (clinicaltrials.gov) - Nov 27, 2018
P2, N=37, Not yet recruiting, Sponsor: Fudan University
- | 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)
Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2020 --> Nov 2018 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