The Modified Combo i3+3 Design for Novel-Novel Combination Dose-Finding Trials in Oncology
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arXiv
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| Autori principali: | , , , |
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| Natura: | Preprint |
| Pubblicazione: |
2024
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| _version_ | 1866913491314540544 |
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| author | Liu, Jiaxin Yuan, Shijie Deng, Qiqi Ji, Yuan |
| author_facet | Liu, Jiaxin Yuan, Shijie Deng, Qiqi Ji, Yuan |
| contents | We consider a modified Ci3+3 (MCi3+3) design for dual-agent dose-finding trials in which both agents are tested on multiple doses. This usually happens when the agents are novel therapies. The MCi3+3 design offers a two-stage or three-stage version, depending on the practical need. The first stage begins with single-agent dose escalation, the second stage launches a model-free combination dose finding for both agents, and optionally, the third stage follows with a model-based design. MCi3+3 aims to maintain a relatively simple framework to facilitate practical application, while also address challenges that are unique to novel-novel combination dose finding. Through simulations, we demonstrate that the MCi3+3 design adeptly manages various toxicity scenarios. It exhibits operational characteristics on par with other combination designs, while offering an enhanced safety profile. The design is motivated and tested for a real-life clinical trial. |
| format | Preprint |
| id |
arxiv_https___arxiv_org_abs_2406_12666 |
| institution | arXiv |
| publishDate | 2024 |
| record_format | arxiv |
| spellingShingle | The Modified Combo i3+3 Design for Novel-Novel Combination Dose-Finding Trials in Oncology Liu, Jiaxin Yuan, Shijie Deng, Qiqi Ji, Yuan Applications We consider a modified Ci3+3 (MCi3+3) design for dual-agent dose-finding trials in which both agents are tested on multiple doses. This usually happens when the agents are novel therapies. The MCi3+3 design offers a two-stage or three-stage version, depending on the practical need. The first stage begins with single-agent dose escalation, the second stage launches a model-free combination dose finding for both agents, and optionally, the third stage follows with a model-based design. MCi3+3 aims to maintain a relatively simple framework to facilitate practical application, while also address challenges that are unique to novel-novel combination dose finding. Through simulations, we demonstrate that the MCi3+3 design adeptly manages various toxicity scenarios. It exhibits operational characteristics on par with other combination designs, while offering an enhanced safety profile. The design is motivated and tested for a real-life clinical trial. |
| title | The Modified Combo i3+3 Design for Novel-Novel Combination Dose-Finding Trials in Oncology |
| topic | Applications |
| url | https://arxiv.org/abs/2406.12666 |