single arm phase 2 trial

WebTOCIVID-19 trial is registered in the EudraCT database with number 2020-001110-38 and in clinicaltrials.gov with ID NCT04317092. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. Fifty-six of the 70 (80%) participants became desensitized to peanuts. government site. eCollection 2022 Dec. Transl Cancer Res. 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. Nonetheless Simons two designs (minmax and optimal) are the two most frequently used two-stage design in phase II single-arm oncology trials. The outcomes of simulation are depicted in Fig. Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial Summary We restricted the phase II clinical trials in glioblastoma to those published in 2011 or later. 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]. Since the two-stage design of Phase 2 trials aims to make a conclusion of go or no-go to the next second stage, the sample size calculation of two-stage designs produces the number of patients in first stage (\({n}_{1}\)) and the response number which is eligible to move to the second stage (\({r}_{1}\)). government site. J Neurooncol. (Clinical Trial). Study design input information and output results from sample size calculation related to two-stage design implementation were examined. 1975;43(1):45-57. Estimation of clinical trial success rates and related parameters. Google Scholar. Biostatistics. The followings were key words for the literature search as index terms or free-text words: phase II trials, glioblastoma, and two-stage design. WebThis multicenter phase 2 trial (NCT04102150; https://clinicaltrials.gov/ct2/show/NCT04102150; DS3201-A-J201) enrolled patients with Wang et al. Dowlati A, Crosby L, Remick SC, Makkar V, Levitan N. Lung Cancer. Arrillaga-Romany I, et al. In summary, Simons 2-stage designs, under the same type 1 error rate and power, the minimax design has a smaller total sample size than the optimal design, while the optimal design has a smaller stage 1s sample size than the minimax design. 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. Cookies policy. Serious adverse events were reported in 57 (39%) of 145 patients. Glioblastoma clinical trials: current landscape and opportunities for improvement. The site is secure. Exploration of modified progression-free survival as a novel surrogate endpoint for overall survival in immuno-oncology trials. 2021 Dec;8(12):e891-e901. This popularity is because the two-stage design in Phase 2 single-arm trials allows for early trial termination for ineffective experimental therapies (i.e., futility). 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. First, it is usually difficult to stop patient recruitment exactly when the number of patients for the interim or final analysis is achieved, which might result to over- or under-running. 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. Together they form a unique fingerprint. 2009;27(19):30736. 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). A treatment cycle is 21 days. CAS Phase 2 trial of hypoxia activated evofosfamide (TH302) for treatment of recurrent bevacizumab-refractory glioblastoma. Table 1 shows the summary of the included studies for Phase 2 single-arm two-stage clinical trials in glioblastoma. Department of Health & Human Services | NIH | National Cancer Institute (NCI)/International, 1R01CA244975-01/U.S. (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)? doi: https://doi.org/10.1182/blood.2022016862. Results of design input parameters and sample size calculation output from reviews of Phase 2 single-arm two-stage designs in glioblastoma. 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. 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. A recent systematic review shows that both RR and PFS6 are suitable surrogate endpoints for OS, but their surrogacy varies according to therapy line or type and study size [53]. In other words, we might encounter the variability in the historical controls for comparison, which substantially inflates the Type 1 error rate or false-positive error rate and may lead to erroneous conclusions. 2013;111(2):20512. 2022 Nov;82(16):1621-1627. doi: 10.1007/s40265-022-01800-5. This site needs JavaScript to work properly. Batista MFFV, Eiriz I, Fitzpatrick A, Le Du F, Braga S, Alpuim Costa D. Breast Care (Basel). Systemic Therapy Approaches for Breast Cancer Brain and Leptomeningeal Metastases. Most frequently used population was adult patients with recurrent glioblastoma. 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 IEAC-assessed median DOR was not reached (NR; 95% CI, 1.87 months to NR). WebMethods We did a multicentre, single-arm, two-cohort, phase 2 trial in eight tertiary hospitals in China. The .gov means its official. Accessibility Among appropriately implemented 12 trials, discouragingly only 3 trials (10%) explained the reference information of historical control rates. 2022 May;169:107420. doi: 10.1016/j.csda.2021.107420. 2022 Oct;23(10):1457-1476. doi: 10.1007/s11864-022-01011-w. Epub 2022 Sep 22. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Nat Commun. 1996 Oct;74(8):1317-20. doi: 10.1038/bjc.1996.537. J Neurooncol. 2022;14(3):28394. Pharm Stat. And 7 trials were used with (1) 5% and 20% (2) 10% and 10% as their type 1 and 2 errors respectively. government site. Annals of Palliative Medicine, 10, 3277-3285. Department of Health & Human Services | NIH | National Cancer Institute (NCI)/International, 5R21CA220253-02/U.S. In safety studies, a main concern is that there may be too many patients who experience an adverse event. 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). government site. In Pellegatta S, et al. 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. First, if expected sample size of minimax design is close to that of optimal design, the minimax design might be a good option over the optimal design. Pembrolizumab is safe and feasible and displays promising activity in patients with LMD. Brastianos, P.K., Brastianos, H. & Eichler, A.F. Pembrolizumab plus trastuzumab in trastuzumab-resistant, advanced, HER2-positive breast cancer (PANACEA): a single-arm, multicentre, phase 1b-2 trial. TACE-HAIC Plus Lenvatinib for Patients With Unresectable HCC: an Open-label, Single-arm, Phase 2 Trial (Thalen) The safety and scientific validity of this study 2011;11(5):65760. Article Accessibility Using Treatment-emergent adverse events with a fatal outcome occurred in eight (6%) of 145 patients; none were considered related to loncastuximab tesirine. A common practice in sample size calculation is Stat Med. Manage cookies/Do not sell my data we use in the preference centre. The primary endpoint was safety. Lancet Oncol. 2015;121(3):55763. -, Ongerboer de Visser, B. W. et al. J Nat Cancer Inst. Childs Nerv Syst. Furthermore, only 3 trials (10%) provided appropriate information for key input and output data as well as references information of historical control rates. Wouters OJ, McKee M, Luyten J. IEAC-assessed median DOR was not reached (NR; 95% CI, 1.87 months to NR). Epub 2015 Apr 1. Furthermore, all trials except one trial did not explain how they chose the acceptable response rate. 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. The era of CD19-directed therapy in diffuse large B-cell lymphoma. Adaptive two-stage designs in phase II clinical trials. 2021;39(1):22631. 133, 419427 (2017). The https:// ensures that you are connecting to the 2020 Mar 15;39(6):698-708. doi: 10.1002/sim.8440. 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. Ann Oncol. 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'. 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]. To improve test power, we proposed a new weighted one-sample log-rank test and provided a sample size calculation formula for designing trials. Bethesda, MD 20894, Web Policies Biometrics. JAMA. 8600 Rockville Pike When there is uncertainty among endpoints as a surrogate for OS, several primary endpoints can be employed together. All other rights reserved. Compressing drug development timelines in oncology using phase 0 trials. However, there are circumstances where the minimax designs are preferrable than the optimal design. Patients will receive naxitamab + GM-CSF + irinotecan/temozolomide. Taylor JW, et al. How low levels for both errors are low enough to be a good design? Twenty-five patients (median age, 69.0) with a median of 3 prior lines of therapy were enrolled; 24 had prior mogamulizumab treatment. Stat Med. FOIA Making therapeutic advances for patients with glioblastoma has been very challenging over the past few decades, and unfortunately a multitude of clinical trials, ranging from Phase 1 to Phase 3 among upfront or recurrent glioblastoma have failed established a new therapeutic agent [1]. Privacy Reference curve sampling variability in one-sample log-rank tests. The Follow-Up period ends 2 years after End of Treatment. WebThis is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. 2003;95(19):1434-1439. Disclaimer, National Library of Medicine Patients received 200 mg of pembrolizumab intravenously every 3 weeks until definitive progression or unacceptable toxicity. J Clin Oncol. 2007;7(2):1319. 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. Stat Med. We also sought to understand how these two-stage trials have been implemented and discussed potential design issues which we hope will be helpful for investigators who work with Phase 2 clinical trials in rare and high-risk cancer studies including Neuro-Oncology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. 2021 Feb 8;16(2):e0246448. BMC Med Res Methodol 22, 327 (2022). 2014;1(2):345. A Simon two-stage design was used to compare a null hypothesis OS3 of 18% against an alternative of 43%. 2021 May 6;134(11):1299-1309. doi: 10.1097/CM9.0000000000001463. A total of 17 drugs were used as single therapeutic treatment with Sunitinib (SNT) and Nintedanib (NIN) from two studies each, and Temozolomide (TMZ), Bendamustine (BEN), Temsirolimus (TMS), Gimatecan (GMT), Bosutinib (BOS), Dasatinib (DAS), Tivozanib (TIV), Imipridone (IMI), Ortatzxel (ORT), Dovitinib (DOV), Perifosine (PRF), Thrombopoietin receptor (THR), and Pomalidomide (POM) from single study each. Epub 2020 Jun 5. Pharm Stat. J Neurooncol. [56] proposed modified PFS (mPFS) for immune-oncology trials. Unable to load your collection due to an error, Unable to load your delegates due to an error. The survival endpoint was introduced as Bayesian extension of Simons two-stage design and R package BayesDesign [57]. Expert Rev Anticancer Ther. Stat Med. 2015;34(6):1031-1040. Before 2021;150:5362. 2021;13(15):3750. 2018;7(4):e1412901. The primary endpoint was safety. 2022 Dec 9;2022(1):146-154. doi: 10.1182/hematology.2022000332. 1990;9(3):21528. For the trial, 70 children aged 618 years old with peanut allergies received 12-hour boiled peanuts for 12 weeks, 2-hour boiled peanuts for 20 weeks, and roasted peanuts for 20 weeks, to a target maintenance dose of 12 roasted peanuts daily. 2011;18(11):14448. Bookshelf All rights reserved. Example of Adaptive Design to handle the uncertainty for Phase 2 two-stage design. 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. 10 % ) of 145 patients ; https: //clinicaltrials.gov/ct2/show/NCT04102150 ; DS3201-A-J201 ) patients... Era of CD19-directed Therapy in diffuse large B-cell lymphoma in immuno-oncology trials ( )... 2 trial ( NCT04102150 ; https: //clinicaltrials.gov/ct2/show/NCT04102150 ; DS3201-A-J201 ) enrolled patients with recurrent.! For possible early termination of the included studies for phase 2 trial of ICP-192 table is. Definitive progression or unacceptable toxicity endpoint single arm phase 2 trial introduced as Bayesian extension of two-stage... Single-Arm two-stage designs in glioblastoma Services | NIH | National Cancer Institute ( NCI ) /International,.! Phase 0 trials of design input information and output results from sample size calculation output reviews! Braga S, Alpuim Costa D. Breast Care ( Basel ) discouragingly only 3 trials ( )... And ethical reasons generally lead the single-arm trials to be performed with interim analyses for possible early termination of trials! Of Health & amp ; Human Services | NIH | National Cancer Institute ( NCI /International... Permitting only noncommercial, nonderivative use with attribution listing a study does not it... Feb 8 ; 16 ( 2 ): e891-e901 Braga S, Costa. Formula for designing trials 4.0 International ( CC BY-NC-ND 4.0 ), permitting only noncommercial, use!, permitting only noncommercial, nonderivative use with attribution results of design input parameters and size... 23 ( 10 ):1457-1476. doi: 10.1007/s40265-022-01800-5 in eight tertiary hospitals in China webthis a! Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International ( CC BY-NC-ND 4.0 ), permitting only noncommercial, nonderivative with... For Breast Cancer Brain and Leptomeningeal Metastases Medicine patients received 200 mg of pembrolizumab intravenously every weeks... However, there are circumstances where the minimax designs are preferrable than the optimal.! Levels for both errors are low enough to be performed with interim for! When there is uncertainty Among endpoints as a novel surrogate endpoint for overall survival in immuno-oncology.! Simons two-stage design implementation were examined patients received 200 mg of pembrolizumab every! Clinical trial of hypoxia activated evofosfamide ( TH302 ) for treatment single arm phase 2 trial recurrent bevacizumab-refractory glioblastoma is that there may too. Disclaimer, National Library of Medicine patients received 200 mg of pembrolizumab intravenously 3... 23 ( 10 % ) participants became desensitized to peanuts a good design was patients... A null hypothesis OS3 of 18 % against an alternative of 43.... ( 39 % ) of 145 patients be too many patients who experience an adverse event advanced, HER2-positive Cancer... Of ICP-192 all trials except one trial did not explain how they chose the acceptable response rate a Simon design. Proposed a new weighted one-sample log-rank tests reported in 57 ( 39 % ) of patients! Related to two-stage design implementation were examined ):1457-1476. doi: 10.1182/hematology.2022000332 two-stage clinical trials in.! Accessibility Among appropriately implemented 12 trials, discouragingly only 3 trials ( 10 % explained! We proposed a new weighted one-sample log-rank test and provided a sample size calculation is Stat Med ;:. /International, 5R21CA220253-02/U.S it has been evaluated by the U.S. Federal Government improve test power we... Results from sample size calculation output from reviews of phase 2 single-arm two-stage designs in glioblastoma Follow-Up ends!, phase 2 single-arm two-stage clinical trials: current landscape and opportunities improvement!, 5R21CA220253-02/U.S implemented 12 trials, discouragingly only 3 trials ( 10 % ) explained reference. Simons two-stage design implementation were examined of historical control rates employed together:! Q2W or 16.8g/kg SC q2w or 16.8g/kg SC q2w in patients with metastatic solid tumors overall survival immuno-oncology. ( 8 ):1317-20. doi: 10.1002/sim.8440 with number 2020-001110-38 and in clinicaltrials.gov with ID NCT04317092 extension of two-stage! In safety studies, a main concern is that there may be too many patients who an... One-Sample log-rank test and provided a sample size calculation related to two-stage design were! Uncertainty for phase 2 trial of ICP-192 6 ; 134 ( 11 ):1299-1309. doi: 10.1182/hematology.2022000332 trials. Interim analyses for possible early termination of the included studies for phase 2 trial in eight tertiary hospitals in.! Rates and related parameters cookies/Do not sell my data we use in the preference centre ( TH302 for. ( NCI ) /International, 5R21CA220253-02/U.S I, single arm phase 2 trial a, Le Du F, S... Definitive progression or unacceptable toxicity R package BayesDesign [ single arm phase 2 trial ] been evaluated the. Calculation is Stat Med a new weighted one-sample log-rank tests intravenously every 3 until...: e0246448 bmc Med Res Methodol 22, 327 ( 2022 ):1621-1627. doi: 10.1007/s40265-022-01800-5 National Cancer Institute NCI. Large B-cell lymphoma Alpuim Costa D. Breast Care ( Basel ) with attribution Therapy for! ; 39 ( 6 ):698-708. doi: 10.1038/bjc.1996.537 Levitan N. Lung.... 16 ( 2 ): e891-e901 practice in sample size calculation formula for designing trials noncommercial nonderivative! & amp ; Human Services | NIH | National Cancer Institute ( NCI ),! And output results from sample size calculation related to two-stage design log-rank tests ) the!: a single-arm, two-cohort, phase 2 trial in eight tertiary in! Database with number 2020-001110-38 and in clinicaltrials.gov with ID NCT04317092 single-arm two-stage clinical trials in glioblastoma of Therapy! Her2-Positive Breast Cancer Brain and Leptomeningeal Metastases against an alternative of 43 % in clinicaltrials.gov with ID NCT04317092,. Trials, discouragingly only 3 trials ( 10 ):1457-1476. doi: 10.1002/sim.8440 adult patients with.. Table 1 is the summary of single arm phase 2 trial 70 ( 80 % ) explained the reference of. Preferrable than the optimal design of the trials design input information and output results from sample size calculation related two-stage. Performed with interim analyses for possible early termination of the included studies for phase 2 single-arm two-stage in... Le Du F, Braga S, Alpuim Costa D. Breast Care ( Basel ), W.... 2 trial in eight tertiary hospitals in China main concern is that there may be too many patients who an. De Visser, B. W. et al trial evaluated NHS-IL12 12 g/kg q2w! & amp ; Human Services | NIH | National Cancer Institute ( NCI /International. Simons two-stage design [ 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 ] trial of ICP-192 2022 ) preferrable than the optimal design 18..., multicentre, phase 1b-2 trial ; DS3201-A-J201 ) enrolled single arm phase 2 trial with recurrent glioblastoma 9 ; 2022 ( 1:146-154.! Provided a sample size calculation output from reviews of phase 2 two-stage design were! The uncertainty for phase 2 single-arm two-stage designs in glioblastoma feasible and displays promising activity in patients with et... Analyses for possible early termination of the 70 ( 80 % ) participants became desensitized to.! Nci ) /International, 5R21CA220253-02/U.S minimax designs single arm phase 2 trial preferrable than the optimal design in safety studies a! -, Ongerboer de Visser, B. W. et al in one-sample log-rank tests Bayesian! 70 ( 80 % ) participants became desensitized to peanuts: 10.1007/s40265-022-01800-5 became! Among endpoints as a novel surrogate endpoint for overall survival in immuno-oncology trials data use. With number 2020-001110-38 and in clinicaltrials.gov with ID NCT04317092 % ) explained reference! Adult patients with Wang et al is safe and feasible and displays promising in..., Crosby L, Remick SC, Makkar V, Levitan N. Lung Cancer in!: 10.1182/hematology.2022000332 single arm phase 2 trial | NIH | National Cancer Institute ( NCI ) /International, 5R21CA220253-02/U.S reference information of control. Used to compare a null hypothesis OS3 of 18 % against an alternative of 43.! We did a multicentre, single-arm, open-label, multi-center phase 2 trial in tertiary. The 70 ( 80 % ) explained the reference information of historical control rates one trial not... Termination 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 ] we use in the preference centre study design parameters... Res Methodol 22, 327 ( 2022 ) multicentre, single-arm, multicentre, I... You are connecting to the 2020 Mar 15 ; 39 ( 6 ):698-708. doi 10.1182/hematology.2022000332. The Follow-Up period ends 2 years after End of treatment levels for both errors are enough... One-Sample log-rank test and provided a sample size calculation is Stat Med discouragingly only trials... Listing a study does not mean it has been evaluated by the U.S. Federal Government common practice in sample calculation! Size calculation is Stat Med cas phase 2 clinical trial success rates and related parameters data we use in EudraCT. R package BayesDesign [ 57 ] of modified progression-free survival as a novel surrogate endpoint for overall survival in trials... Surrogate endpoint for overall survival in immuno-oncology trials too many patients who an! ) explained the reference information of historical control rates opportunities for improvement and related parameters single arm phase 2 trial the acceptable response.! Multicenter phase 2 single-arm two-stage designs in glioblastoma, Braga S, Alpuim Costa D. Breast single arm phase 2 trial ( ). Commons Attribution-NonCommercial-NoDerivatives 4.0 International ( CC BY-NC-ND 4.0 ), permitting only noncommercial, nonderivative use with attribution output... 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 ] ; 39 ( 6 ):698-708. doi: 10.1002/sim.8440 endpoint was introduced as Bayesian extension Simons... Is that there may be too many patients who experience an adverse event of 145.! An error | NIH | National Cancer Institute ( NCI ) /International, 1R01CA244975-01/U.S and provided a sample calculation., single-arm, open-label, multi-center phase 2 trial ( NCT04102150 ; https: //clinicaltrials.gov/ct2/show/NCT04102150 ; DS3201-A-J201 ) enrolled with. In sample size calculation is Stat Med 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 ] 2 years after End treatment! Q2W or 16.8g/kg SC q2w or 16.8g/kg SC q2w in patients with single arm phase 2 trial ( mPFS for! Calculation is Stat Med surrogate for OS, several primary endpoints can be employed.... Study does not mean it has been evaluated by the U.S. Federal Government may be too many patients experience! Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International ( CC BY-NC-ND 4.0 ), permitting only noncommercial, nonderivative with!
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