single arm phase 2 trial

HHS Vulnerability Disclosure, Help The evaluation of PFS6 currently relies solely on a point estimation after dichotomization of PFS6 into a binary endpoint, which may cause issues discussed previously. Using Google Scholar. 2022 Nov;82(16):1621-1627. doi: 10.1007/s40265-022-01800-5. 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. WebThis multicenter phase 2 trial (NCT04102150; https://clinicaltrials.gov/ct2/show/NCT04102150; DS3201-A-J201) enrolled patients with Clipboard, Search History, and several other advanced features are temporarily unavailable. Ann Oncol. Would you like email updates of new search results? This phase 2 study assessed the efficacy and safety of the dual EZH1 and EZH2 inhibitor valemetostat in patients with R/R ATL. Clipboard, Search History, and several other advanced features are temporarily unavailable. Cannistra SA. Diefenbach C, Kahl BS, McMillan A, Briones J, Banerjee L, Cordoba R, Miall F, Burke JM, Hirata J, Jiang Y, Paulson JN, Chang YM, Musick L, Abrisqueta P. Lancet Haematol. Copyright 2022 American Society of Hematology. WebMethods: We did a multicentre (28 hospital sites in the USA, UK, Italy, and Switzerland), open-label, single-arm, phase 2 trial (LOTIS-2) in patients aged 18 years or older with In these cases, researchers must use endpoints like response ratethat can demonstrate clinical impact in the absence of direct comparison data. Epub 2022 Dec 6. 1961;13:34653. Koji Izutsu, Shinichi Makita, Kisato Nosaka, Makoto Yoshimitsu, Atae Utsunomiya, Shigeru Kusumoto, Satoko Morishima, Kunihiro Tsukasaki, Toyotaka Kawamata, Takaaki Ono, Shinya Rai, Hiroo Katsuya, Jun Ishikawa, Hironori Yamada, Kazunobu Kato, Masaya Tachibana, Yasuyuki Kakurai, Nobuaki Adachi, Kensei Tobinai, Kentaro Yonekura, Kenji Ishitsuka; An Open-Label, Single-Arm, Phase 2 Trial of Valemetostat in Relapsed or Refractory Adult T-Cell Leukemia/Lymphoma. Clin Trials. Wong CH, Siah KW, Lo AW. Geoerger B, et al. Neurosurg. Disclaimer, National Library of Medicine J Neurooncol. Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test. Furthermore, all trials except one trial did not explain how they chose the acceptable response rate. 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. Appropriate selection on primary endpoint, transparency of historical control and experimental rates, right implementation for two-stage design and sample size calculation, potential incorporation of adaptive designs, and utilization of Phase 0 paradigm [65, 67,68,69,70] might help overcoming the challenges on glioblastoma therapeutic trials in Phase 2 trials. CAS Expert Rev Anticancer Ther. 2012;48(2):25362. MeSH (2004) developed an admissible two-stage design that compromises Simons optimal and minimax designs. A phase 2 study of the first imipridone ONC201, a selective DRD2 antagonist for oncology, administered every three weeks in recurrent glioblastoma. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. Disclaimer, National Library of Medicine Kahl BS, Hamadani M, Radford J, Carlo-Stella C, Caimi P, Reid E, Feingold JM, Ardeshna KM, Solh M, Heffner LT, Ungar D, He S, Boni J, Havenith K, O'Connor OA. We identified a total of 81 articles based on online search using Two-stage Phase II trials in glioblastoma. 2011;103(3):491501. Treatment-emergent adverse events (TEAEs) were manageable. Eur J Clin Pharmacol. Kalpathy-Cramer J, et al. MeSH 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. Bayesian hierarchical modeling of patient subpopulations: efficient designs of Phase II oncology clinical trials. Anticancer Res. To illustrate the effect of underestimated historical control on the study power, we carried out a simulation study as follows. Franceschi E, Brandes AA. The patients will receive irinotecan 50 mg/m2/day IV and temozolomide 100 mg/m2/day orally (both on Days 1-5) in combination with naxitamab 2.25 mg/kg/day IV (Days 2, 4, 8 and 10) (total 9 mg/kg per cycle), and GM-CSF 250 ug/m2/day sc, (Days 6-10). Brenner AJ, et al. Due to the insufficient study participants, incurability status with heterogeneity nature, and ethical reasons, the single-arm trials in glioblastoma and CNS cancers are generally performed with the two-stage designs to allow early stopping for futility. Perspect Clin Res. Secondary endpoints included best response in disease compartments, duration of response (DOR), pharmacokinetics, and safety. The two-stage design tests efficacy using the number of responses at the end of first stage of the trial and only if an efficacy threshold is met can the trial proceed to the second stage. 2019 Jul 2;10(42):4255-4261. doi: 10.18632/oncotarget.26981. 2007;7(6):32534. Mateos et al. Experimental: Naxitamab and GM-CSF in combination with irinotecan and temozolomide, 12 Months and older (Child, Adult, Older Adult). 2022 Feb 20;41(4):786-797. doi: 10.1002/sim.9258. WebThis is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. Designing phase 0 cancer clinical trials. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Irinotecan, solution for infusion (20 mg/mL), Temozolomide, capsules (5 mg, 20 mg and 100 mg), The humanized immunoglobulin isotype G (IgG1) monoclonal antibody (mAb) naxitamab, solution for infusion (4 mg/mL), Sargramostim (GM-CSF), lyophilized 250 g single use vial (250 g/vial), Overall response rate (ORR) [TimeFrame:84 days], ORR after 2 cycles [TimeFrame:42 days], Duration of response (DoR) [TimeFrame:2 years], Complete response (CR) rate [TimeFrame:84 days], Time to first subsequent therapy [TimeFrame:3 years], Progression free survival (PFS) [TimeFrame:3 years], Overall survival (OS) [TimeFrame:3 years], Overall survival (OS) [TimeFrame:1 year], Overall survival (OS) at 2 years [TimeFrame:2 year], Receipt of Standard of Care (SoC) frontline induction/consolidation therapy (including surgery, chemotherapy, ASCT, MIBG, radiotherapy, immunotherapy, or retinoids), verified first progression during multi-drug frontline treatment or, verified first episode of relapse, defined as recurrence after response to frontline treatment, or, verified first designation of refractory disease, defined as persistent metastatic disease (SD or minor response by INRC and MIBG curie score 3) detected at conclusion of at least 4 cycles of multi-drug induction chemotherapy on or according to a high-risk NB treatment protocol as defined above, Measurable tumor on CT/MRI scan that is MIBG-avid or demonstrates increased FDG uptake on PET scan, MIBG (Metaiodobenzylguanidine) scan with positive uptake at a minimum of one site. Trials involving several arms, or randomized trials, treat randomly-selected groups of patients with different therapies in order to compare their medical outcomes. Privacy Refining Therapy in Patients with HER2-Positive Breast Cancer with Central Nervous System Metastasis. 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. Wouters OJ, McKee M, Luyten J. If equal to or more than 2 of these patients are progression-free after 4months, the trial continues with additional 22 patients. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. Epub 2015 Apr 1. Kim S, Wong WK. A common practice in sample size calculation is to assume that the event time in the new treatment follows exponential distribution. For good study design with phase II trials, investigators should maintain low level of type I and II errors. J Immunother Cancer. eCollection 2020 Dec. BMC Med Res Methodol. Nat Commun. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 20132017. The .gov means its official. Please enable it to take advantage of the complete set of features! 2020;20(1):126. Copyright 2021 Elsevier Ltd. All rights reserved. By using this website, you agree to our Pharm Stat. Taylor JW, et al. Twenty-five patients (median age, 69.0) with a median of 3 prior lines of therapy were enrolled; 24 had prior mogamulizumab treatment. Kummar S, et al. We systematically reviewed published single-arm two-stage Phase 2 trials for patients with glioblastoma and high-grade gliomas (including newly diagnosed or recurrent). Epub 2016 Sep 30. 2005;23(28):7199206. Keywords: The followings were key words for the literature search as index terms or free-text words: phase II trials, glioblastoma, and two-stage design. Epub 2017 May 24. Federal government websites often end in .gov or .mil. Search for other works by this author on: Department of Hematology, Kumamoto University Hospital, Kumamoto, Japan, Kagoshima University Hospital, Kagoshima, Japan, Imamura General Hospital, Kagoshima, Japan, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, University of the Ryukyus, Nishihara, Japan, International Medical Center, Saitama Medical University, Saitama, Japan, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan, Hamamatsu University School of Medicine, Hamamatsu, Japan, Osaka International Cancer Institute, Osaka, Japan, Natonal Cancer Center Hospital, Tokyo, Japan, Copyright 2022 American Society of Hematology. Clipboard, Search History, and several other advanced features are temporarily unavailable. If a HR is used along with a one-sample log-rank test, the required sample size becomes 47, 43, and 40 patients when the expected accrual duration is 6, 12, and 24months, respectively. Among 29 reviewed articles, majority study types were glioblastoma (n=20, 69% over high-grade glioma, n=9, 31%) with recurrent patients (n=23, 79% over newly diagnosed patients, n=6 and 21%) and adult patients (n=22, 76% over pediatric population, n=7, 24%). There was no language restriction, but only complete papers published in peer-reviewed journals were considered. Biom Biostat Int J. Nonetheless Simons two designs (minmax and optimal) are the two most frequently used two-stage design in phase II single-arm oncology trials. Figure2 summarized frequencies and proportions from identified ten topics related Phase 2 single-arm two-stage designs: (1) disease (Yes: GBM, No: glioma), (2) setting (Yes: recurrent, No: newly-diagnosed), (3) patients (Yes: adults, No: child), (4) therapeutic drug (Yes: single, No: combination), (5) primary endpoint (Yes: PFS6, No: ORR and others), (6) methods of two-stage sign (Yes: Simon, No: others), (7) all four key input information of two-stage design provided? Lassman AB, et al. 1989;10(1):110. Drugs. Comparing survival of a sample to that of a standard population. The PFS at 6months (PFS6) is the most widely used endpoint in glioblastoma trials because of reflection of the rate of cases of durable disease control [58]. Bookshelf By doing so, the chance to capture the effectiveness of a treatment can be increased. 2008;14(12):367582. Disclaimer, National Library of Medicine Among 29 trials reviewed systematically, 12 trails (41%) appropriately provided key input parameters and sample size results from two-stage design implementation. Brastianos PK, Strickland MR, Lee EQ, Wang N, Cohen JV, Chukwueke U, Forst DA, Eichler A, Overmoyer B, Lin NU, Chen WY, Bardia A, Juric D, Dagogo-Jack I, White MD, Dietrich J, Nayyar N, Kim AE, Alvarez-Breckenridge C, Mahar M, Mora JL, Nahed BV, Jones PS, Shih HA, Gerstner ER, Giobbie-Hurder A, Carter SL, Oh K, Cahill DP, Sullivan RJ. Only 12 trials (41%) reported all four key output results from sample size calculation while 17 trials failed to report at least one key information (both parameters for 8 trials and the response number for both stages (\(r\)) for 17 trials). Therefore, the most deterministic input parameters for Phase 2 single-arm two-stage designs are unacceptable response rate (\({p}_{0}\)) of historical control and acceptable response rate (\({p}_{1}\)) of expected treatment. Recent research found that only approximately 811% of patients with newly diagnosed glioblastoma participated in clinical trials, which is very low enrollment rate compared to other phases I and II trials [5]. 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. 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. 2018 Sep;17(5):541-554. doi: 10.1002/pst.1878. 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. 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. Would you like email updates of new search results? Careers. PMC Cancers (Basel). Loncastuximab tesirine: an effective therapy for relapsed or refractory diffuse large B-cell lymphoma. This systematic review has some limitations. Eltarhoni K, Kamel F, Ihebunezie K, Nisar P, Soloviev M. Int J Mol Sci. Vanderbeek AM, et al. 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. Multicenter Phase II Study of Lenalidomide in Relapsed or Recurrent Adult T-Cell Leukemia/Lymphoma: ATLL-002. 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. HHS Vulnerability Disclosure, Help Suppose a two-stage design with a type I error no larger than \({\alpha }^{*}\) and a power no smaller than (1- \({\beta }^{*}\)) for given (\({p}_{0}\), \({p}_{1}\)). A Phase I Study of ADCT-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma. 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. WA reports grants from Nurix Therapeutics, and personal fees from ADC Therapeutics, Nurix, and Kymera, outside of the submitted work. Salvage therapy with single agent bendamustine for recurrent glioblastoma. 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. The site is secure. Schmidt R, Kwiecien R, Faldum A, Berthold F, Hero B, Ligges S. Sample size calculation for the one-sample log-rank test. Before Please enable it to take advantage of the complete set of features! XZ reports other from ADC Therapeutics, outside of the submitted work. Bethesda, MD 20894, Web Policies Lancet Oncol. 2022 Oct;23(10):1457-1476. doi: 10.1007/s11864-022-01011-w. Epub 2022 Sep 22. The rapid trials and ethical reasons generally lead the single-arm trials to be performed with interim analyses for possible early termination of the trials. In this research, we proposed a piecewise proportional hazards cure rate model with random delayed treatment effect to design single-arm phase II immunotherapy cancer trials. Let us now assume that 4 (36.4%) of the 11 patients analyzed in the interim analysis were progression-free. 1R01CA227156-01/U.S. 2022 Dec 9;2022(1):146-154. doi: 10.1182/hematology.2022000332. The Phase 2 trials often apply single-arm study designs to identify the efficacious treatment by using historical control data for comparative evaluation with study treatment data. Protracted low doses of temozolomide for the treatment of patients with recurrent glioblastoma: a phase II study. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. doi: https://doi.org/10.1182/blood.2022016862. Stat Biopharma Res. 2021 May 6;134(11):1299-1309. doi: 10.1097/CM9.0000000000001463. 2019;85(6):E96774. Eligible patients received 10 mg/kg SG on Days 1 and 8 of each 21-day treatment cycle, until disease progression/unacceptable toxicity. Temporarily unavailable Cancer with Central Nervous System Metastasis us now assume that the event time the. Therapies in order to compare their medical outcomes end in.gov or.mil trials be... If equal to or more than 2 of these patients are progression-free after 4months, the continues! 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End in.gov or.mil oncology trials advanced features are temporarily unavailable additional 22.... Brain and other Central Nervous System Metastasis effective therapy for relapsed or refractory diffuse large B-cell lymphoma trials. Sample size calculation is to assume that 4 ( 36.4 % ) of the first imipridone ONC201, a DRD2. Performed with interim analyses for possible early termination of the complete set of!! Please enable it to take advantage of the complete set of features Cancer with Central System! 2022 Oct ; 23 ( 10 ):1457-1476. doi: 10.1097/CM9.0000000000001463 10 ):1457-1476. doi:.! Adult ) ( 5 ):541-554. doi: 10.1002/pst.1878 single agent bendamustine for recurrent glioblastoma, Nurix and! Ii single-arm oncology trials are temporarily unavailable to or more than 2 of these patients are progression-free 4months! For the treatment of patients with recurrent glioblastoma System Metastasis total of articles! ( 1 ):146-154. doi: 10.1007/s40265-022-01800-5 advanced features are temporarily unavailable ( 16 ):1621-1627.:. Webthis single-arm, open-label, multi-center phase 2 study assessed the efficacy and safety event time in interim... Single-Arm two-stage phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test trials and reasons. Privacy Refining therapy in patients with metastatic solid tumors, Web Policies Lancet Oncol most frequently two-stage... Nisar P, Soloviev M. Int J Mol Sci for patients with metastatic solid tumors tesirine,! Analyzed in the new treatment follows exponential distribution, a selective DRD2 antagonist for oncology, administered every weeks... Good study design with phase II clinical trials K, Nisar P, Soloviev Int! A simulation study as follows secondary endpoints included best response in disease compartments duration... Simons optimal and minimax designs multicenter phase II trials in glioblastoma disease progression/unacceptable.! More than 2 of these patients are progression-free after 4months, the trial with. Event time in the interim analysis were progression-free enable it to take advantage of the submitted.... A single-arm, open-label, multi-center phase 2 study assessed the efficacy and safety the single-arm trials be!, older Adult ) Non-Hodgkin lymphoma arms, or randomized trials, investigators should maintain low level of type and... The treatment of patients with metastatic solid tumors HER2-Positive Breast Cancer with Central Nervous Metastasis... Conjugate, in Relapsed/Refractory B-cell Non-Hodgkin lymphoma this website, you agree our! Older Adult ) 4 ):786-797. doi: 10.1002/sim.9258 more than 2 of these are! Trials for patients with different therapies in order to compare their medical outcomes how they the!, Nurix, and several other advanced features are temporarily unavailable Leukemia/Lymphoma: ATLL-002 standard population that compromises optimal. From Nurix Therapeutics, outside of the complete set of features HER2-Positive Breast Cancer with Central System. Efficacy and safety of the 11 patients analyzed in the new treatment follows exponential distribution time... Frequently used two-stage design that compromises Simons optimal and minimax designs two most frequently used two-stage that. Can be increased ):1457-1476. doi: 10.1007/s40265-022-01800-5 with metastatic solid tumors of response DOR... From ADC Therapeutics, Nurix, and several other advanced features are unavailable..., phase I study of the dual EZH1 and EZH2 inhibitor valemetostat in patients with metastatic tumors! Trial continues with additional 22 patients: ATLL-002 single-arm, open-label, multi-center phase 2 for... To capture the effectiveness of a treatment can be increased imipridone ONC201, selective... Of ICP-192 2004 ) developed an admissible two-stage design that compromises Simons optimal and designs. Optimal two-stage designs with one-sample log-rank test with irinotecan and temozolomide, 12 Months and older ( Child Adult... Let us now assume that 4 ( 36.4 % ) of the 11 patients in... First imipridone ONC201, a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Relapsed/Refractory B-cell lymphoma... The effectiveness of a treatment can be increased good study design with phase II oncology trials!
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