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c ¨È·à±d-KY»PBIOGENETICS¦X§@ñqVARLITINIB«nÁú¦a°Ï°Ó«~¤ÆÅv§Q±ÂÅv®× (2019 02 )
B 2020¦~6¤ë¥ª¥k§¹¦¨¤@½uÁx¹DÀù¤G´ÁÁ{§É ¥DnÀø®Ä«ü¼Ð¦p¤U: Phase 2A: Objective Response Rate (ORR) Phase 2A: Progression Free Survival (PFS) Phase 2B: Progression Free Survival (PFS)
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3 Ó¤H¸ÑŪ part 1 ¤G´Á127¤H¼Æ¾Ú¹F¼Ð´N·|ª½±µ¥Ó½ÐÃÄÃÒ(·|¦³³oºØ±ø¥ó·íµM¬O©t¨àÃÄ¥[¤W¥Ø«eµL¦³®Äªº¤G½uÃÄ¥i¥Î) ,¥b«H¥bºÃªº·à¤Í¥i¦A°Ý¤½¥q, FDA ¦b¤G´Á§¹¦¨¥Ó½Ð®ÖµoÃÄÃÒªº¨Ò¤lÁÙ¤£¤Ö,¤]¦³¤@´Á°µ§¹´Nª½±µ¥Ó½ÐÃÄÃÒ,«Ü¦³¼u©Ê!
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Study Description
Brief Summary: This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by simultaneous inhibition of these receptors. The purpose of this study is to determine the safety and efficacy of Varlitinib in combination with capecitabine for the treatment of Biliary Tract Cancer. Treatment groups are Varlitinib+capecitabine and Placebo + capecitabine
Detailed Description: Part 1 of study(Phase 2) is planned to have 120 patients and anticipated completion on July 2019. Recruitment completed. Part 2 of study(Phase 3) is planned to have 350 patients and anticipated completion on Dec 2022. Not yet recruiting.
clinicaltrials.gov/ct2/show/NCT03093870 Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer (TreeTopp)
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1.Primary Outcome Measures : Incidence of Adverse events (AE) - safety lead-in [ Time Frame: Through 28-days post last study medication administration ] Safety-lead-in: Incidence of AEs, categorized in accordance to CTCAE 4.03 and changes from baseline in safety parameters (including vital signs, ECG parameters, clinical laboratory tests)
2.Objective response rate (ORR) - part 1 [ Time Frame: the later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event in Part 1 ] Part 1: ORR defined as the proportion of subjects with a best objective response (BOR) of complete response (CR) or partial response (PR), as assessed by an Independent Central Review(ICR) defined by the RECIST v1.1 criteria
3.Progression-free survival (PFS) - part 1 [ Time Frame: The later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event in Part 1 ] Part 1: Progression-free survival (PFS), defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined in accordance with the RECIST v1.1 criteria and will be derived programmatically based on data from the ICR of radiological data.
4.Overall survival (OS) - part 2 [ Time Frame: When 247 OS events have occurred. With median OS times of 8.6 months and 6 months for respective arms, 247 OS is estimated to occur after approximately 31 months. ] Part 2; Overall survival (OS) Defined as the time from randomization until death by any cause
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¤Ñ©R¤j ¨È·à±d¥þ²y¤T´Á¥Dn«ü¼Ð¬O Objective response rate (ORR) Progression-free survival (PFS)
¦¸n«ü¼Ð¬OOverall survival (OS )
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Exploratory objectives: ¡E Part1 1. To explore the role of HER family status as a predictor of benefit to varlitinib 2. To explore possible relationships between HER family and downstream signaling protein and phospho-protein expression levels and clinical outcomes 3. To explore possible relationships between gene mutational status and clinical outcomes ¡E Part2 If a relationship is found between biomarker(s) expression and clinical outcomes in Part 1 of the study, the biomarker(s) could be prospectively evaluated in Part 2 of the study.
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Figure 1 Survival outcomes with second-line fluoropyrimidine-based chemotherapy. Progression-free survival (A) and overall survival (B).
www.ncbi.nlm.nih.gov/pmc/articles/PMC5344285/#!po=2.38095
Efficacy of fluoropyrimidine-based chemotherapy in patients with advanced biliary tract cancer after failure of gemcitabine plus cisplatin: retrospective analysis of 321 patients
www.ncbi.nlm.nih.gov/pmc/articles/PMC5344285/
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The main characteristics of the 32 eligible studies for aggregation are shown in [Table 1]. A total of 2885 BTC patients were included in this meta-analysis. In all the 32 studies, the expression of HER-2, c-MET, and EGFR was confirmed by IHC.
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1.Incidence of Adverse events (AE) - safety lead-in [ Time Frame: Through 28-days post last study medication administration ] Safety-lead-in: Incidence of AEs, categorized in accordance to CTCAE 4.03 and changes from baseline in safety parameters (including vital signs, ECG parameters, clinical laboratory tests)
2.Objective response rate (ORR) - part 1 [ Time Frame: the later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event in Part 1 ] Part 1: ORR defined as the proportion of subjects with a best objective response (BOR) of complete response (CR) or partial response (PR), as assessed by an Independent Central Review(ICR) defined by the RECIST v1.1 criteria
3.Progression-free survival (PFS) - part 1 [ Time Frame: The later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event in Part 1 ] Part 1: Progression-free survival (PFS), defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined in accordance with the RECIST v1.1 criteria and will be derived programmatically based on data from the ICR of radiological data.
4.Overall survival (OS) - part 2 [ Time Frame: When 247 OS events have occurred. With median OS times of 8.6 months and 6 months for respective arms, 247 OS is estimated to occur after approximately 31 months. ] Part 2; Overall survival (OS) Defined as the time from randomization until death by any cause
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¦b1,278¦W°Ñ»P¦¨¤H¤¤¡A¯SÀ³©Ê¥Öª¢ªº±w¯f²v¡]95¢H¸m«H°Ï¶¡¡^¬°7.3¢H¡]5.9-8.8¡^¡C Á`Åé¦Ó¨¥¡A60.1¢H¡]56.1-64.1¡^ªº°Ñ»PªÌ³Q¤ÀÃþ¬°»´«×¡A 28.9¢H¡]25.3-32.7¡^¬°¤¤«×¡A 11¢H¬°ÄY«¡]8.6-13.7¡^¯e¯f¡C
¯SÀ³©Ê¥Öª¢±wªÌ©M±w¦³ÄY«¯e¯fªº±wªÌ¦b¥Ö½§¯f¥Í¬¡½è¶q«ü¼Æ¤¤±o¤À¸û°ª¡]AD±wªÌªº¥§¡[¼Ð·Ç®t] = 4.71 [6.44]»P¹ï·Ó²Õ¬Û¤ñ= 0.97 [2.12]¡^¡]P <0.001¡^©MÂå°|µJ¼{¡]AD±wªÌªº¥§¡[¼Ð·Ç®t] = 7.03 [4.80]»P¹ï·Ó²Õ¬Û¤ñ= 4.73 [4.8]¡^©M§íÆ{¯g¡]AD±wªÌªº¥§¡È¡A[¼Ð·Ç®t] = 5.83 [4.54]»P¹ï·Ó²Õ¬Û¤ñ= 3.62 [ 3.61]¡^¶qªí¡Aªí©ú¹ï¥Í¬¡½è¶qªº¼vÅT§óÄY«¡AµJ¼{©Î§íÆ{ªº¥i¯à©Ê¼W¥[¡C
®Ú¾Ú§Ú̪º±w¯f²v¦ôp¡A1650¸U¦¨¦~¤H±N¶EÂ_¥X¯SÀ³©Ê¥Öª¢¡A¨ä¤¤660¸U¤H²Å¦X¤¤«×¦Ü««×¯e¯fªº¼Ð·Ç¡C§Ú̪º¬ã¨sÃÒ¹ê¤F¸Ó¤H¸s¤¤¯SÀ³©Ê¥Öª¢ªº°ª±w¯f²v©M¯e¯ft¾á¡C
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www.ncbi.nlm.nih.gov/pubmed/30389491
Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population.
Population-based estimates on the prevalence of atopic dermatitis in adults vary widely. The objectives of this study were to determine the prevalence of atopic dermatitis in the population of the United States, the distribution of disease severity, and its impact on health-related quality of life. Among 1,278 participating adults, the prevalence (95% confidence interval) of atopic dermatitis was 7.3% (5.9-8.8). Overall, 60.1% (56.1-64.1) of participants were classified as having mild, 28.9% (25.3-32.7) as having moderate, and 11% as having severe (8.6-13.7) disease. Patients with atopic dermatitis and those with more severe disease had higher scores in the dermatology life quality index (mean [standard deviation] for AD patients = 4.71 [6.44] vs. control individuals = 0.97 [2.12]) (P < 0.001) and the hospital anxiety (mean [standard deviation] for AD patients = 7.03 [4.80] vs. control individuals = 4.73 [4.8]) and depression (mean, [standard deviation] for AD patients = 5.83 [4.54] vs. control individuals = 3.62 [3.61]) scales, indicating a worse impact on quality of life and an increased likelihood of anxiety or depression. Based on our prevalence estimates, 16.5 million adults would have a diagnosis of atopic dermatitis, with 6.6 million meeting criteria for moderate to severe disease. Our study confirms the high prevalence and disease burden of atopic dermatitis in this population.
Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.
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FDA§åãDupixent®¡]dupilumab¡^ªvÀø«C¤Ö¦~¤¤««×¯SÀ³©Ê¥Öª¢
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FDA approves Dupixent® (dupilumab) for moderate-to-severe atopic dermatitis in adolescents
* Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation that underlies atopic dermatitis
* In a Phase 3 trial, Dupixent significantly reduced the extent and severity of disease and itching, and helped adolescents achieve clearer skin
News provided by Sanofi „\ Mar 11, 2019, 15:45 ET
The approval of Dupixent for adolescents with moderate-to-severe atopic dermatitis means that for the first time these patients and their families, who often help them manage this debilitating disease, will have access to a first-of-its-kind biologic treatment that has already been used to treat approximately 50,000 patients in the U.S., said John Reed, M.D., Ph.D., Head of Research and Development at Sanofi. Our Phase 3 data demonstrated that Dupixent treatment significantly improved skin lesions, reduced itching, and helped clear the skin of these adolescent patients. |
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