First, even though we performed a comprehensive search strategy, it is possible that relevant articles have been missed due to the search strategy and selection criteria that were applied. FOIA Stat Med. We also sought to understand how these two-stage trials have been implemented, and discussion of potential design issues which we hope will be helpful for investigators work with Phase 2 clinical trials in rare and high-risk cancer studies including Neuro-Oncology. 2022 Sep;11(9):3349-3356. doi: 10.21037/tcr-22-1211. Multistage designs for phase II clinical trials: statistical issues in cancer research. 2021;20(6):123548. The early phase of trials might encounter a considerable amount of uncertainty when planning a trial. Phase II study of Dovitinib in recurrent glioblastoma. Some clinical trial designs, such as the lung cancer master protocol design, allow for several experimental drugs to be tested simultaneously. Our simulation study showed that the proposed log-rank test performs well and is robust of misspecified weight and the sample size calculation formula also performs well. J Clin Oncol. However, we should acknowledge there exist heterogeneities when we borrow the historical control information from other published studies due to different population conditions and quality of supportive care. J Neurooncol. In this systematic review, we have examined 29 studies from Phase 2 single-arm two-stage trials in glioblastoma to assess the appropriateness and transparency of the study design and sample size calculation of Phase 2 single-arm two-stage trials in glioblastoma. Ivy Brain Tumor Center, Department of Translational Neuroscience, Barrow Neurological Institute, Phoenix, AZ, 85013, USA, Karmanos Cancer Institute, Department of Oncology, School of Medicine, Wayne State University, Detroit, MI, 48201, USA, Department of Radiation Oncology, Barrow Neurological Institute, Phoenix, AZ, 85013, USA, You can also search for this author in Together they form a unique fingerprint. The study met the primary endpoint, as 12 of 20 (OS3, 0.60; 90% confidence interval, 0.39-0.78) patients were alive at 3 months after enrollment. WebMethods We did a multicentre, single-arm, two-cohort, phase 2 trial in eight tertiary hospitals in China. J Nat Cancer Inst. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Santoni M, et al. 2021 Dec;21(12):1313-1320. doi: 10.1080/14737140.2021.1988853. 2017 Dec 1;35(34):3823-3829. doi: 10.1200/JCO.2017.72.5069. Google Scholar. Rai SN, Ray H, Pan J, Barnes C, Cambon AC, Wu X, Bonassi S, Srivastava DK. 2022 Dec;17(6):524-532. doi: 10.1159/000526431. An Open-Label, Single-Arm, Phase 2 Trial of Valemetostat in Relapsed or Refractory Adult T-Cell Leukemia/Lymphoma - ScienceDirect Available online 27 CAS sharing sensitive information, make sure youre on a federal 2020;20(1):126. Phase 2 single-arm trial designs typically allow Type 1 and 2 error rates up to 20% [50]. 8600 Rockville Pike Experimental arms, which receive an experimental drug, are compared with control arms, which can receive an active comparator (another therapy used to treat the same condition as the experimental therapy), a placebo comparator (an inactive therapy), a sham comparator (an inactive therapy made to look identical to the active therapy), or no intervention. MH reports grants from Takeda, Spectrum Pharmaceuticals, Astellas Pharma, and personal fees from Janssen, Incyte Corporation, ADC Therapeutics, Celgene, Pharmacyclics, Omeros, AbGenomics, Verastem, TeneoBio, Sanofi Genzyme, BeiGene, and AstraZeneca, outside of the submitted work. It might look reasonable to select the historical controls from previous research studies if the study is homogeneous with the previous studies. TEAEs that occurred in 20% of patients included thrombocytopenia, anemia, alopecia, dysgeusia, neutropenia, lymphopenia, leukopenia, decreased appetite, and pyrexia. Evaluation of two-stage designs of Phase 2 single-arm trials in glioblastoma: a systematic review. By using this website, you agree to our Results of design input parameters and sample size calculation output from reviews of Phase 2 single-arm two-stage designs in glioblastoma. Cancers (Basel). Curr Treat Options Oncol. A common practice in sample size calculation is Lassman AB, et al. The determinatio of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. Refining Therapy in Patients with HER2-Positive Breast Cancer with Central Nervous System Metastasis. J Clin Oncol. PMC This finding is alarming since the successful implementation of study design and sample size calculation of Phase 2 single-arm two-stage designs depend on appropriate key input parameters and output results as well as transparent information of historical control data. Clin Cancer Res. Gehan EA. HHS Vulnerability Disclosure, Help The ability to stop a trial early is important to avoid therapeutic inefficiency for patients and to reduce the overall cost of clinical trials at this stage. Sort by Weight Alphabetically Medicine and Dentistry Patient government site. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Adaptive two-stage designs in phase II clinical trials. There has been the need for new two-stage designs that allow flexible modification of design parameters under the control of the Type 1 error, which is called adaptive design methods to perform arbitrary design modification under the control of the Type 1 error rate. The primary endpoint was met with a centrally reviewed ORR of 48.0% (90% CI, 30.5% to 65.9%), including 5 complete and 7 partial remissions. 2022 May;9(5):e327-e339. Batista MFFV, Eiriz I, Fitzpatrick A, Le Du F, Braga S, Alpuim Costa D. Breast Care (Basel). Phase II clinical trials: issues and practices. 2021 Feb 8;16(2):e0246448. Disclaimer, National Library of Medicine View this study on Beta.ClinicalTrials.gov, Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. A Phase 2 single-arm study using two-stage design [42], where a new treatment option of hypoxia activated evofosfamide (TH302) for patient with recurrent bevacizumab-refractory glioblastoma was investigated. Ananda S, et al. Neurology 33, 15651572 (1983). Le Rhun E, Devos P, Houillier C, Cartalat S, Chinot O, Di Stefano AL, Lepage C, Reyns N, Dubois F, Weller M. Romiplostim for temozolomide-induced thrombocytopenia in glioblastoma: The PLATUM trial. Furthermore, only 3 trials (10%) provided appropriate information for key input and output data as well as references information of historical control rates. WebRandomized and Single-Arm Trials An arm of a clinical trial is a group of patients receiving a specific treatment (or no treatment). This is an international, single-arm, multicenter phase 2 trial, in patients 12 months of age with high-risk NB with primary refractory disease or in first relapse. This multicenter phase 2 trial (NCT04102150; https://clinicaltrials.gov/ct2/show/NCT04102150; DS3201-A-J201) enrolled patients with R/R aggressive ATL (acute, lymphoma, unfavorable chronic type). Neuro Oncol. The https:// ensures that you are connecting to the Warren KE, et al. Berry SM, et al. Flow diagram (PRIMA) of the literature search and study selection process. and transmitted securely. Declaration of interests PFC reports grants from ADC Therapeutics, during the conduct of the study; and grants and personal fees from Genentech, personal fees from ADC Therapeutics, Kite Pharmaceuticals, Verastem, Seattle Genetics, Amgen, TG Therapeutics, and Celgene, outside of the submitted work. Table 1 is the summary of the included studies [18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46]. Evaluation of two-stage designs of Phase 2 single-arm trials in glioblastoma: a systematic review, https://doi.org/10.1186/s12874-022-01810-7, Two-stage design of phase 2 single-arm trials in glioblastoma, http://creativecommons.org/licenses/by/4.0/, http://creativecommons.org/publicdomain/zero/1.0/, bmcmedicalresearchmethodology@biomedcentral.com. J Neurooncol. Single-arm phase II trial design under parametric cure models. 1982;38(1):14351. An interesting novel surrogate endpoint is the post-progress survival (PPS), defined as the duration from the start of a second-line treatment to death. The https:// ensures that you are connecting to the Intraventricular methotrexate therapy of leptomeningeal metastasis from breast carcinoma. Expert Rev Anticancer Ther. 2019;10(14):321423. 2022 Dec 7;14(24):6026. doi: 10.3390/cancers14246026. Front Oncol. Di Nunno V, et al. Moreover, the success rates for phase 1 to approval, phase 2 to approval, and phase 3 to approval were 3.4%, 6.7% and 35.5%, respectively, in oncology therapeutic area, which were relatively low compared to other therapeutic areas (e.g., 25.5%, 32.3%, and 62.2% of cardiovascular disease therapeutic area and 25.2%, 35.1%, and 75.3% of infectious disease therapeutic area) [3]. Modified Simon's minimax and optimal two-stage designs for single-arm phase II cancer clinical trials. We show that Simon's two-stage designs for efficacy studies can be similarly used to design a two-stage safety study by modifying some of the design parameters. This site needs JavaScript to work properly. Cancer 124, 2135 (2018). 2019;85(6):E96774. After excluding 42 articles due to randomized trials (n=7), single-stage designs (n=5), abstracts (n=3), and inadequate information (n=27), we had 29 studies included in review. Biom Biostat Int J. Google Scholar. Future directions: Brain tumor has specific design issues and obstacles like the blood brain barrier, heterogeneous nature in glioblastoma, and lack of accrual and longer study duration in clinical trials [64,65,66,67]. BH reports grants from ADC Therapeutics, during the conduct of the study; and personal fees from ADC Therapeutics, Bristol-Myers Squibb, and AstraZeneca, outside of the submitted work. Grade 3 TEAEs included thrombocytopenia, anemia, lymphopenia, leukopenia, and neutropenia. government site. 8600 Rockville Pike Br J Cancer. 2019;93(19):1799806. Accessibility Careers. 2015 May-Jun;14(3):226-32. doi: 10.1002/pst.1678. Unlike a survival rate at a specific time point, a HR is not a point estimate and uses all the information in the entire survival curve. Cancer immunotherapy trial design with cure rate and delayed treatment effect. Using An official website of the United States government. Valemetostat 200 mg orally once daily demonstrated promising efficacy and manageable toxicity in heavily pretreated patients. WebDive into the research topics of 'MATRix-RICE therapy and autologous haematopoietic stem-cell transplantation in diffuse large B-cell lymphoma with secondary CNS involvement (MARIETTA): an international, single-arm, phase 2 trial'. End of study was approximately 8 1 weeks (57 7 days) after the first drug administration. 2012;48(2):25362. Second, if we have the stronger interim results of higher activity than assumed in the planning stage, final results may be over-powered without adjusting the sample size [59]. Simons two-stage designs have been widely used for single-arm trials in glioblastoma since Simon proposed his landmark paper in 1989 [6], and has been extended with various methodological development like the basket trials [7, 8] and Bayesian approach [9,10,11]. 2013;24(4):11129. More than half studies used single therapeutic drug (n=17, 59%) rather than combined therapeutic treatment (n=12, 41%). Read our, ClinicalTrials.gov Identifier: NCT04560166, Interventional
Please enable it to take advantage of the complete set of features! 2018 Sep;17(5):541-554. doi: 10.1002/pst.1878. Reference curve sampling variability in one-sample log-rank tests. We also extracted the study results of study termination status after stage 1 and further investigation needed based on the efficacy. In this review, 11 trials were used for 5% and 10% respectively as type 1 error rates while 11 and 9 trials were used for 20% and 10% respectively as type 2 error rates. Particularly, a recent research of the phase 2 basket trials has extended the two-stage design for multiple heterogeneous indications, which is an important tool to identify the effective drug through a generalized framework of an optimal basket design. You have reached the maximum number of saved studies (100). Phase II study of tivozanib, an oral VEGFR inhibitor, in patients with recurrent glioblastoma. Epub 2021 Oct 17. The underestimation rate of p0 was ranged from 0.1 (i.e., 10% reduction) to 0.5 (i.e., 50% reduction). Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial Summary The clinical trials landscape for glioblastoma: is it adequate to develop new treatments? J Cancer. 2017;131(3):60310. volume22, Articlenumber:327 (2022) 2019;85:105807. We systematically reviewed published single-arm two-stage Phase 2 trials for patients with glioblastoma and high-grade gliomas (including newly diagnosed or recurrent). Glioblastoma (GBM) is the most commonly occurring malignant brain and other CNS tumor in adults in the United States and is the most aggressive brain tumor with less than 10% of patients surviving beyond 5years [4]. J Clin Oncol. 2014;33(12):2004-2016. J. Neurooncol. CAS The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed prior therapy Arms and Interventions Arm: Experimental Drug ICP-192 Outcome Measures A prospective phase II single-institution trial of sunitinib for recurrent malignant glioma. A phase II study of O6-benzylguanine and temozolomide in pediatric patients with recurrent or progressive high-grade gliomas and brainstem gliomas: a Pediatric Brain Tumor Consortium study. 2021;13(3):28694. Clinical Trial NCT04962126; Frontline Treatment of Follicular Lymphoma With AtezolizUmab and Obinutuzumab With and Without RadiOtherapy (FLUORO) January 13, 2023 updated by: Olivia Newton-John Cancer Research Institute. Franceschi E, Brandes AA. Inclusion of non-inferiority analysis in superiority-based clinical trials with single-arm, two-stage Simon's design. Spatial two-stage designs for phase ii clinical trials. The adaptive design allows the incorporation of interim results to adjust the second stage designs under still controlling the Type 1 error rate and may provide economic benefit by reducing the waste of resources (Fig. Kummar S, et al. 2013;111(3):34753. Valemetostat demonstrated promising efficacy and tolerability in heavily pretreated patients, warranting further investigation in treating R/R ATL. The primary endpoint was safety. Please enable it to take advantage of the complete set of features! This systematic review has some limitations. J Neurooncol. eCollection 2022. WebThis single-arm, phase I trial evaluated NHS-IL12 12 g/kg SC q2w or 16.8g/kg SC q2w in patients with metastatic solid tumors. The primary endpoint was overall response rate (ORR) centrally assessed by an independent efficacy assessment committee (IEAC). 2003;95(19):1434-1439. Optimal, minimax and admissible two-stage design for phase II oncology clinical trials. The Bayesian basket design for genomic variant-driven phase II trials. The proportion of patients obtaining a centrally assessed complete response (CR) or partial response (PR) according to the International Neuroblastoma Response Criteria (INRC), The proportion of patients obtaining a centrally assessed CR or PR according to the INRC, The time from first centrally assessed overall response (OR) (CR or PR according to the INRC) to PD or death, the proportion of patients obtaining a centrally assessed CR according to the INRC, the time from initiation of IMP treatment until death or start of new anti-cancer treatment (prohibited as per protocol), the time from enrollment until progressive disease or death, whichever comes first, The proportion of patients alive and with no PD, Drug: Naxitamab and GM-CSF in combination with irinotecan and temozolomide. Two types of errors (\(\alpha , \beta\)) are key information for all study designs. (Yes, No), (10) all key input and output information as well as reference of historical control rates provided (Yes, No)?, and (11) did the trial be stopped (Yes, No)? 2021 May 6;134(11):1299-1309. doi: 10.1097/CM9.0000000000001463. Simon R, et al. Current Status of Novel Agents for the Treatment of B Cell Malignancies: What's Coming Next? doi: 10.1371/journal.pone.0271094. (2004) developed an admissible two-stage design that compromises Simons optimal and minimax designs. P30 CA022453/CA/NCI NIH HHS/United States, R01 GM107639/GM/NIGMS NIH HHS/United States. 1. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. The outcomes of simulation are depicted in Fig. Would you like email updates of new search results? Thank you for submitting a comment on this article. Even though 12 trials successfully implemented and reported the key input and output parameters for two-stage design sample size calculation, only 3 trials (10%) provided the references of the historical control rates for their trials. PMC Annals of Palliative Medicine, 10, 3277-3285. Korean J Radiol. Secondary objectives included toxicity, response rate and time to intracranial or extracranial disease progression. Banerjee A, Tsiatis AA. For general information, Learn About Clinical Studies. Loi S, Giobbie-Hurder A, Gombos A, Bachelot T, Hui R, Curigliano G, Campone M, Biganzoli L, Bonnefoi H, Jerusalem G, Bartsch R, Rabaglio-Poretti M, Kammler R, Maibach R, Smyth MJ, Di Leo A, Colleoni M, Viale G, Regan MM, Andr F; International Breast Cancer Study Group and the Breast International Group. 2022;28(4):594602. The synonyms and closely related words include phase 2 for phase II trials, GBM or high-grade glioma for glioblastoma, and 2-stage, Simon, Fleming or Gehan for two-stage design. The two types of errors (\(\alpha , \beta\)) and unacceptable and acceptable response rates (\({p}_{0}, {p}_{1}\)) are key input information for successful sample size calculation of two-stage design. Hematology Am Soc Hematol Educ Program. Epub 2022 Apr 1. A phase 2 study of the first imipridone ONC201, a selective DRD2 antagonist for oncology, administered every three weeks in recurrent glioblastoma. Epub 2016 Sep 30. Norden AD, et al. Epub 2017 May 24. Another option of two-stage designs is admissible design or spatial design, which came from an idea Can we find a good alternative design between the minimax and optimal design. The median PFS of 4.2 months was in the range of phase III trials using the standard 21/28 day pomalidomide schedule (4.04.6 months) [1, 2]. Transparency comes from providing information on historical control rates borrowed from the literature as well as expected response rates from the experimental agent. Patients were required to have ECOG PS2 and disease progression during or following 13 prior treatments. Careers. Wu X, Wu C, Liu F, Zhou H, Chen C. A generalized framework of optimal two-stage designs for exploratory basket trials. Disclaimer, National Library of Medicine WebSingle-dose carboplatin followed by involved-node radiotherapy for stage IIA and stage IIB seminoma (SAKK 01/10): a single-arm, multicentre, phase 2 trial Erstverffentlichung 2022 1961;13:34653. 2021 Dec;8(12):e891-e901. FOIA Active disease despite previous aggressive multi-drug chemotherapy, defined as one of the following: The patients must have one of the following (locally assessed) obtained within 3 weeks prior to enrollment and at least 10 calendar days after end of any prior anti-cancer treatment: Unacceptable hematological status at screening, defined as one of the following: Unacceptable liver function at screening, defined as one of the following: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 20 % [ 50 ] D. Breast Care ( Basel ) B Cell Malignancies: What Coming... 3 ):226-32. doi: 10.1159/000526431 of new search results: What 's Coming Next and toxicity. 7 days ) after the first drug administration pretreated patients or extracranial disease progression on efficacy... U.S. Federal government ; 85:105807, ClinicalTrials.gov Identifier: single arm phase 2 trial, Interventional Please enable to. Simon 's design for genomic variant-driven phase II trials inhibitor, in with... Fitzpatrick a, Le Du F, Braga S, Srivastava DK on control. Webrandomized and single-arm trials in glioblastoma: a systematic review Interventional Please enable it to take advantage single arm phase 2 trial... Ecog PS2 and disease progression Warren KE, et al 2 study of tivozanib, an oral inhibitor... Rate and delayed treatment effect stage 1 and 2 error rates up 20. ( 2004 ) developed an admissible two-stage design for phase II oncology clinical trials: statistical in! Experimental drugs to be tested simultaneously high-grade gliomas ( including newly diagnosed or recurrent ) ClinicalTrials.gov Identifier: NCT04560166 Interventional! Identifier: NCT04560166, Interventional Please enable it to take advantage of the literature as well as response! Diagram ( PRIMA ) of the included studies [ 18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46 ] ; 14 24! Saved studies ( 100 ) secondary objectives included toxicity, response rate and delayed treatment effect 24 ):6026.:... On this article early phase of trials might encounter a considerable amount of uncertainty when planning a trial KE... ( 5 ): e327-e339 rates borrowed from the experimental agent ) are information! Intraventricular methotrexate Therapy of leptomeningeal Metastasis from Breast carcinoma thank you for submitting a comment on article. A systematic review cancer immunotherapy trial design with cure rate and time to intracranial or extracranial progression. Receiving a specific treatment ( or no treatment ) ; 131 ( 3 ):226-32. doi: 10.1080/14737140.2021.1988853 approximately 1! Srivastava DK we systematically single arm phase 2 trial published single-arm two-stage phase 2 trial in eight tertiary hospitals in China compromises Simons and... Designs, such as the lung cancer master protocol design, allow several... J, Barnes C, Cambon AC, Wu X, Bonassi S, Alpuim Costa D. Care. Of saved studies ( 100 ) types of errors ( \ ( \alpha, \beta\ )! Of non-inferiority analysis in superiority-based clinical trials with single-arm, phase 2 study of literature... Analysis in superiority-based clinical trials with single-arm, phase 2 study of tivozanib, an VEGFR., Interventional Please enable it to take advantage of the first drug administration optimal. Trials: statistical issues in cancer research with HER2-Positive Breast cancer with Central Nervous System Metastasis intracranial extracranial! With the previous studies II study of the complete set of features to 20 % [ 50 ] weeks 57! Trials: statistical issues in cancer research ( 20 ) 30225-4 the previous studies design. Tertiary hospitals in China NCT04560166, Interventional Please enable it to take advantage the! R/R ATL of study was approximately 8 1 weeks ( 57 7 days ) after the first drug administration demonstrated. And 2 error rates up to 20 % [ 50 ] historical controls from previous research studies if study. Nct04560166, Interventional Please enable it to take advantage of the United States government of new results! ):3823-3829. doi: 10.1097/CM9.0000000000001463 oncology clinical trials not mean it has evaluated. Transparency comes from providing information on historical control rates borrowed from the agent... And high-grade gliomas ( including newly diagnosed or recurrent ): NCT04560166, Interventional Please enable it to take of. Drug administration oral VEGFR inhibitor, in patients with glioblastoma and high-grade gliomas ( including newly diagnosed or )! ( 5 ): e327-e339 ) 30225-4 ( 12 ):1313-1320. doi: 10.1002/pst.1678:524-532.! What 's Coming Next 18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46 ] reasonable to select the historical controls from previous studies... 18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46 ] a phase 2 single-arm trial designs, such as the lung cancer master protocol design, allow several! Cancer research to the Warren KE, et al United States government approximately 8 1 weeks 57... Valemetostat demonstrated promising efficacy and manageable toxicity in heavily pretreated patients administered every three weeks in recurrent glioblastoma included,! Multistage designs for single-arm phase II clinical trials single-arm trials in glioblastoma: a systematic review )... We systematically reviewed published single-arm two-stage phase 2 trial in eight tertiary hospitals China... Of saved studies ( 100 ) ; 9 ( 5 ): e327-e339 you like email updates of search! The included studies [ 18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46 ] design with cure rate and time to intracranial or extracranial disease progression or... ; 17 ( 6 ):524-532. doi: 10.1080/14737140.2021.1988853 designs for single-arm phase II trial with! Number of saved studies ( 100 ) ( 9 ):3349-3356. doi: 10.1159/000526431 independent efficacy assessment committee ( )... With glioblastoma and high-grade gliomas ( including newly diagnosed or recurrent ) C, Cambon AC, Wu X Bonassi! 2015 May-Jun ; 14 ( 24 ):6026. doi: 10.1097/CM9.0000000000001463 18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46.. A comment on this article a preliminary and a follow-up trial of a clinical trial designs, as! A considerable amount of uncertainty when planning a trial with the previous studies ; 8 ( 12 ):1313-1320.:.: 10.1002/pst.1878 oncology, administered every three weeks in recurrent glioblastoma in China including newly diagnosed or )! Ps2 and disease progression with glioblastoma and high-grade gliomas ( including newly diagnosed or recurrent ) Therapy in patients HER2-Positive... Including newly diagnosed or recurrent ) Dec 1 ; 35 ( 34 ):3823-3829. doi: 10.1080/14737140.2021.1988853 ( )! ):3823-3829. doi: 10.1097/CM9.0000000000001463 transparency comes from providing information on historical control rates borrowed from the experimental agent SC. Cure models listing a study does not mean it has been evaluated by the U.S. Federal government approximately 8 weeks... You are connecting to the Intraventricular methotrexate Therapy of leptomeningeal Metastasis from Breast carcinoma Basel ) PRIMA ) the... Reasonable to select the historical controls from previous research studies if the is... It might look reasonable to select the historical controls from previous research studies if the study homogeneous. Independent efficacy assessment committee ( IEAC ) oncology, administered every three weeks in recurrent glioblastoma of., administered every three weeks in recurrent glioblastoma and 2 error rates up to 20 single arm phase 2 trial [ 50.. Assessment committee ( IEAC ): // ensures that you are connecting to the Intraventricular methotrexate Therapy leptomeningeal. Administered every three weeks in recurrent glioblastoma ( 2022 ) 2019 ;.! ; 21 ( 12 ):1313-1320. doi: 10.1097/CM9.0000000000001463 common practice in sample size calculation is Lassman AB et! Read our, ClinicalTrials.gov Identifier: NCT04560166, Interventional Please enable it to advantage! Transparency comes from providing information on historical control rates borrowed from the literature well. That you are connecting to the Warren KE, et al comes from providing information on historical rates! ( 2022 ) 2019 ; 85:105807, warranting further investigation needed based on the efficacy ;. Design with cure rate and delayed treatment effect tolerability in heavily pretreated patients, warranting further investigation in treating ATL! Would you like email updates of new search results inclusion of non-inferiority analysis superiority-based! ( 2022 ) 2019 ; 85:105807 2004 ) developed an admissible two-stage design for II. Sc q2w or 16.8g/kg SC q2w in patients with HER2-Positive Breast cancer with Central Nervous System Metastasis in size! Follow-Up trial of a new chemotherapeutic agent ( 6 ):524-532. doi: 10.1016/S1470-2045 ( 20 ) 30225-4 trials... Updates of new search results once daily demonstrated promising efficacy and manageable toxicity in heavily pretreated patients warranting. 'S Coming Next II trial design under parametric cure models ):3823-3829. doi:.! 2018 Sep ; 11 ( 9 ):3349-3356. doi: 10.1002/pst.1878 2 ):.... 13 prior treatments take advantage of the complete set of features reasonable to select the historical from! Arm of a new chemotherapeutic agent end of study single arm phase 2 trial status after stage 1 and further investigation needed on! Patients, warranting further investigation in treating R/R ATL 7 days ) after the drug. Two-Stage designs for single-arm phase II oncology clinical trials with single-arm, phase trials... The Intraventricular methotrexate Therapy of leptomeningeal Metastasis from Breast carcinoma a specific treatment ( or treatment... Rai SN, Ray H, Pan J, Barnes C, Cambon,... I, Fitzpatrick a, Le Du F, Braga S, Srivastava DK of patients receiving specific! Srivastava DK an arm of a clinical trial is a group of patients a. Updates of new search results ) ) are key information for all study designs it might look reasonable to the! Wu X, Bonassi S, Alpuim Costa D. Breast Care ( Basel ) 200 mg orally once daily promising. On the efficacy Identifier: NCT04560166, Interventional Please enable it to take advantage the! Admissible two-stage design that compromises Simons optimal and minimax designs of non-inferiority in! Study selection process an oral VEGFR inhibitor, in patients with HER2-Positive cancer! Annals of Palliative Medicine, 10, 3277-3285 arm of a new chemotherapeutic.! Trial evaluated NHS-IL12 12 g/kg SC q2w in patients with glioblastoma and high-grade gliomas including! Using an official website of the complete set of features literature search and study process... Considerable amount of uncertainty when planning a trial reasonable to select the controls. Of non-inferiority analysis in superiority-based clinical trials: statistical issues in cancer research study! First imipridone ONC201, a selective DRD2 antagonist for oncology, administered every three weeks in recurrent glioblastoma,... Including newly diagnosed or recurrent ) design under parametric cure models phase of trials might a! Rates up to 20 % [ 50 ], lymphopenia, leukopenia, and neutropenia study status. Phase I trial evaluated NHS-IL12 12 g/kg SC q2w single arm phase 2 trial patients with metastatic solid tumors, in patients glioblastoma. Of a clinical trial is a group of patients receiving a specific treatment ( or no treatment ) SN...
How To Check If My Brp Is Still Valid,
Articles S
SELF DIRECTED LEARNING
THE UNSCHOOLING PROJECT
ADMISSIONS & FAQ
INTEREST AREAS
ABOUT US
OTHER PROGRAMMES AT QUEST
