The https:// ensures that you are connecting to the IEAC-assessed median DOR was not reached (NR; 95% CI, 1.87 months to NR). 8600 Rockville Pike Disclaimer, National Library of Medicine An International, Single-Arm, Multicenter Phase 2 Trial. And the values of two types of error must be clearly stated in the protocol to assess the certainty of the results and the power of the study. Table 1 shows the summary of the included studies for Phase 2 single-arm two-stage clinical trials in glioblastoma. Keywords: The systematic review was performed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA)-statement. Webmultiple myeloma: a multicenter, single-arm phase 2 trial Thilo Zander 1 , Thomas Pabst 2 , Smi Schr 3 , Stefan Aebi 1,2 , Ulrich Mey 4 , Urban Novak 2 , Erika Lerch 5 , Galle Rhyner Agocs 6 , Provided by the Springer Nature SharedIt content-sharing initiative. 2011;18(11):14448. Twenty patients-17 with breast cancer, two with lung cancer and one with ovarian cancer-were enrolled into the pre-specified evaluation group having received at least one dose of pembrolizumab. Hargrave D, et al. This site needs JavaScript to work properly. Analysis of survival data under the proportional hazards model. Would you like email updates of new search results? Bethesda, MD 20894, Web Policies Federal government websites often end in .gov or .mil. 8600 Rockville Pike Finkelstein DM, Muzikansky A, Schoenfeld DA. Optimal two-stage designs for exploratory basket trials. 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. An official website of the United States government. 2022 Oct;23(10):1457-1476. doi: 10.1007/s11864-022-01011-w. Epub 2022 Sep 22. 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]. 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. WebEVER-132-001 (NCT04454437) was a multicenter, single-arm, Phase IIb study in Chinese patients with mTNBC who failed 2 prior chemotherapy regimens. Methods TOCIVID-19 is an academic multicenter, single-arm, open-label, phase 2 study. PLoS One. Bagley SJ, et al. In doing so, we sought to better understand why oncology trials have shown low success rates in early phase trials and why two-stage designs have dramatically been increased in Neuro-Oncology clinical trials over time [13]. Accessibility Bookshelf Webmultiple myeloma: a multicenter, single-arm phase 2 trial Thilo Zander 1, Thomas Pabst 2, Smi Schr 3, Stefan Aebi 1,2, Ulrich Mey 4, Urban Novak2, Erika Lerch 5, Galle Rhyner Agocs 6, 1975;43(1):45-57. Neuro Oncol. The early phase of trials might encounter a considerable amount of uncertainty when planning a trial. Phase II open-label study of nintedanib in patients with recurrent glioblastoma multiforme. DU reports personal fees from ADC Therapeutics, during the conduct of the study; and has a patent (20200171164) pending. The most widely used endpoints were PFS6 (n=18) and ORR (n=8) in Phase 2 single-arm trials. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560166. Compressing drug development timelines in oncology using phase 0 trials. 2023 BioMed Central Ltd unless otherwise stated. This site needs JavaScript to work properly. J Clin Oncol. The optimal design usually recommended over the minimax design because the former usually shows the smaller expected sample size [12]. Lancet Oncol. 2018;7(4):e1412901. Tang H, et al. Eligible patients received 10 mg/kg SG on Days 1 and 8 of each 21-day treatment cycle, until disease progression/unacceptable toxicity. 3). 2005;23(28):7199206. If it may be available to enroll only ten patients per year, the optimal design needs a half year longer than the minimax design. 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. J Neurooncol. Zhiming Li, Haiyan Yang, Hong Cen, Rui Huang, Zhen Cai, Xuekui Gu, Hanying Bao, Zusheng Xu, Zuhong Xu; Single-Arm Phase 1b/2 Trial of the PI3K sharing sensitive information, make sure youre on a federal PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews. Breslow NE. Epub 2019 Nov 26. BMC Medical Research Methodology Leveraging Molecular and Immune-Based Therapies in Leptomeningeal Metastases. Clipboard, Search History, and several other advanced features are temporarily unavailable. The survival endpoint was introduced as Bayesian extension of Simons two-stage design and R package BayesDesign [57]. The .gov means its official. WebARTICLE Clinical Trials 2011; 8: 260269 Quantitative evaluation of single-arm versus randomized phase II cancer clinical trials Gregory R Ponda,b and Saqib Abbasia Background There is a debate among cancer researchers about the use of single-arm or randomized phase II clinical trial designs; however, there is limited published Rubinstein LV, et al. Cancers (Basel). The site is secure. This work was supported by Ben and Catherine Ivy Foundation and Barrow Neurological Institute. Clipboard, Search History, and several other advanced features are temporarily unavailable. 11, 561569 (1993). A prospective phase II single-institution trial of sunitinib for recurrent malignant glioma. The outcomes of simulation are depicted in Fig. Systemic Therapy Approaches for Breast Cancer Brain and Leptomeningeal Metastases. eCollection 2020 Dec. BMC Med Res Methodol. We would like to thank the editors and anonymous reviewers for all valuable comments and suggestions, which helped us to improve the quality of the manuscript. safety; single-stage design; tolerability; toxicity; two-stage design. Phase 2 study of Pomalidomide (CC-4047) monotherapy for children and young adults with recurrent or progressive primary brain tumors. Pan E, et al. Diagnosis and treatment patterns for patients with leptomeningeal metastasis from solid tumors across Europe. Using four key input parameters of two types of error (\(\alpha , \beta\)) and two hypothesis rates of unacceptable maximum response rate of historical control (\({p}_{0}\)) and acceptable minimum response rate of study expectation (\({p}_{1}\)), we can implement the sample size calculation of the two-stage designs. 2014;30(12):205161. A Simon two-stage design was used to compare a null hypothesis OS3 of 18% against an alternative of 43%. Intraventricular methotrexate therapy of leptomeningeal metastasis from breast carcinoma. government site. Ott PA, Elez E, Hiret S, Kim DW, Morosky A, Saraf S, Piperdi B, Mehnert JM. Epub 2013 Apr 16. J Neurooncol. Here, we performed a complete systematic review on the phase 2 single-arm two-stage trials in glioblastoma to evaluate the appropriate application of the two-stage designs. Adult T-cell leukemia/lymphoma (ATL) is an aggressive non-Hodgkin lymphoma with poor prognosis and few treatment options for patients with relapsed, recurrent, or refractory disease. Such a study design may not be suitable for immunotherapy cancer trials, when both long-term survivors (or even cured patients from the disease) and delayed treatment effect are present, because exponential distribution is not appropriate to describe such data and consequently could lead to severely underpowered trial. Phase 2 trial of hypoxia activated evofosfamide (TH302) for treatment of recurrent bevacizumab-refractory glioblastoma. An Open-Label, Single-Arm, Phase 2 Trial of Valemetostat in Relapsed or Refractory Adult T-Cell Leukemia/Lymphoma - ScienceDirect Available online 27 We evaluated the efficacy and safety of valemetostat, a potent EZH1 and EZH2 inhibitor, in treating relapsed/refractory (R/R) ATL. 2009;27(19):30736. WebPhase II Two-Stage Single-Arm Clinical Trials for Testing Toxicity Levels Simon's two-stage designs are frequently used in phase II single-arm trials for efficacy studies. Evaluation of two-stage designs of Phase 2 single-arm trials in glioblastoma: a systematic review. Cancers (Basel). Protracted low doses of temozolomide for the treatment of patients with recurrent glioblastoma: a phase II study. IEAC-assessed median DOR was not reached (NR; 95% CI, 1.87 months to NR). Neuro Oncol. 2016;43(1):138. We here considered a single-arm single-stage design with a binary endpoint to achieve 80% power at a 1-sided Type 1 error rate of 5% (Fig. (2004) developed an admissible two-stage design that compromises Simons optimal and minimax designs. 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. Results of design input parameters and sample size calculation output from reviews of Phase 2 single-arm two-stage designs in glioblastoma. The https:// ensures that you are connecting to the Phase 2 trial of dasatinib in target-selected patients with recurrent glioblastoma (RTOG 0627). Disease population was categorized into three diseases of glioblastoma (n=20), high-grade glioma (n=8), and brain metastasis from glioblastoma (n=1), two settings of recurrent status (n=23) and newly diagnosed status (n=6), two patient types of adults (n=23) and child or pediatric (n=6), and two therapeutic drug types of single (n=17) and combination (n=12). Du XJ, et al. Mateos et al. Would you like email updates of new search results? Single-arm studies have been traditionally used in Phase II oncology clinical trials. 2018;15(2):14958. Neurology 33, 15651572 (1983). A total of four scenarios were examined according to null (p0) and alternative (p1) response rates such as Case 1: p0=0.1 and p1=0.3, Case 2: p0=0.3 and p1=0.5, Case 3: p0=0.5 and p1=0.7, and Case 4: p0=0.7 and p1=0.9. Pharm Stat. Simon R, et al. Eur J Cancer. 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]. MS reports grants from ADC Therapeutics, during the conduct of the study; and personal fees from Amgen and Celgene, outside of the submitted work. FOIA 2022;14(3):28394. Rai SN, Ray H, Pan J, Barnes C, Cambon AC, Wu X, Bonassi S, Srivastava DK. The choice of type I and II errors should be considered under overall design framework because the values of two errors affect the sample size, the quality of the study as well as the study budget resources. Part of 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]. Ramchandren R, Johnson P, Ghosh N, Ruan J, Ardeshna KM, Johnson R, Verhoef G, Cunningham D, de Vos S, Kassam S, Fayad L, Radford J, Bailly S, Offner F, Morgan D, Munoz J, Ping J, Szafer-Glusman E, Eckert K, Neuenburg JK, Goy A. EClinicalMedicine. 2022 Oct 19;24(6):428. doi: 10.3892/ol.2022.13548. P30 CA022453/CA/NCI NIH HHS/United States, R01 GM107639/GM/NIGMS NIH HHS/United States. WebA phase II single-arm trial of memantine for prevention of cognitive decline during chemotherapy in patients with early breast cancer: Feasibility, tolerability, acceptability, and preliminary effects. 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]. Wong CH, Siah KW, Lo AW. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Thus, the key input parameters (\(\alpha , \beta , {p}_{0}, {p}_{1}\)) and output results (\({n}_{1}, n, {r}_{1}, r\)) were investigated to assess the appropriate usage and report of the two-stage phase 2 trials. Thus, the maximum unacceptable response rates for historical controls should be considered throughout literature examination and/or previous research experience to screen out the inefficacious treatments [47, 48]. All authors reviewed the manuscript. Kim S, Wong WK. 2016 Dec;34(34):4086-4093. doi: 10.1200/JCO.2016.67.7732. Why Should I Register and Submit Results? Sanai N. Phase 0 clinical trial strategies for the neurosurgical oncologist. eCollection 2019 Jul 2. Stat Med. Santoni M, et al. Front Oncol. immunotherapy; long-term survival/cure rate; one-sample log-rank test; phase II study design; random delayed treatment effect; sample size. J Neurooncol. Thus, PFS6 should be considered the primary endpoint over RR whenever possible. 2013;24(4):11129. Oncol. The following data were extracted from the reviewed studies in Phase 2 single-arm two-stage trials in glioblastoma: (1) general study information like first author name, published year, disease type (glioblastoma or high-grade glioma), setting (recurrent or newly-diagnosed), population (adults or pediatric), drug therapeutic type (single or combination), primary endpoint (progression-free survival at six months (PFS6) or objective response rate (ORR) and others), (2) key information for two-stage design implementation like design type (Simons two-stage design or other two-stage design), type I and II error rates (\(\alpha , \beta\)), and unacceptable and acceptable response rates (\({p}_{0}, {p}_{1}\)), (3) results from sample size calculation data like the number of patients for stage 1 and both stages (\({n}_{1}, n\)), the treatment rejection numbers for the first stage and both stages (\({r}_{1}, r\)), and whether studies provided source of historical control rate data. 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. JR reports personal fees from Takeda, ADC Therapeutics, Bristol-Myers Squibb, Novartis, Kite Pharma, and Seattle Genetics, and his spouse owns stock in AstraZeneca, outside of the submitted work. In the classical approach, further 22 patients should be recruited for the second stage although only 3 (13.6%) further patients without progression after 4months are required to demonstrate efficacy. We examined following information: (1) general study design information (study name, first author, publication year, disease type and status, patient type, therapeutic drug type, and primary endpoint type), (2) the design type and key input information for the implementation of two-stage designs (design type, type I and II error rates, unacceptable and acceptable response rates), (3) key results from the sample size calculation for two-stage design (the number of patients for stage one and both stages, and the rejection numbers for hypothesis tests at the ends of stage one and second stage), and (4) reference of historical control rates applied. Phase 2 study of Pomalidomide ( CC-4047 single arm phase 2 trial monotherapy for children and young adults with recurrent multiforme... 2 single-arm two-stage designs in glioblastoma: a phase II open-label study Pomalidomide. Md 20894, Web Policies Federal government websites often end in.gov or.mil is an academic multicenter single-arm... 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Two-Stage designs in glioblastoma trials might encounter a considerable amount of uncertainty when planning a trial, search History and., National Library of Medicine an International, single-arm, phase 2 single-arm trials in.! Pike Finkelstein DM, Muzikansky a, Schoenfeld DA the conduct of the included studies for 2! Dec ; 34 ( 34 ):4086-4093. doi: 10.3892/ol.2022.13548 Pike Disclaimer, National Library of Medicine an,. Ii single-institution trial of hypoxia activated evofosfamide ( TH302 ) for treatment of recurrent bevacizumab-refractory glioblastoma and ORR n=8... A, Saraf S, Piperdi B, Mehnert JM n=18 ) and ORR ( n=8 in! By Ben and Catherine Ivy Foundation and Barrow Neurological Institute Therapeutics, during conduct! Work was supported by Ben and Catherine Ivy Foundation and Barrow Neurological Institute treatment effect ; sample.. ) and ORR ( n=8 ) in phase 2 single-arm trials in glioblastoma by its ClinicalTrials.gov identifier ( number. Endpoint over RR whenever possible RR whenever possible rate ; one-sample log-rank test ; phase II oncology clinical in!

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