Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM)
第1/2相
完了
NCT03410030
| 対象疾患 | Pancreatic Cancer, Pancreas Cancer, Pancreatic Adenocarcinoma Resectable, Pancreatic Ductal Adenocarcinoma |
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| 相 | 第1/2相 |
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| スポンサー | HonorHealth Research Institute |
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| ステータス | 完了 |
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| 参加者数 | 17 名 |
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| 介入（薬剤） | High Dose Ascorbic Acid 25 g/m^2, Nanoparticle Paclitaxel protein bound 125mg/m^2, Cisplatin 25mg/m^2, Gemcitabine 1000mg/m^2, High Dose Ascorbic Acid 37.5 g/m^2 |
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| 開始日 | 2017年12月15日 |
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| 完了日 | 2021年9月14日 |
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| 結果公開日 | 2026年7月23日 |
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概要
The purpose of this study is to see if a treatment regimen with a combination of paclitaxel protein bound (also known as nab-paclitaxel), gemcitabine, and cisplatin when given with high dose Ascorbic Acid will be safe and effective in individuals with untreated metastatic pancreatic cancer.
Total Dose Received [Identifying Recommended Maximum Tolerated Dose (MTD)]
From enrollment through end of treatment, up to 40 weeks · Dose (g/m^2)
| Ascorbic Acid 25 g/m^2 | 235.3 ± 66.3 Dose (g/m^2) |
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| Ascorbic Acid 37.5 g/m^2 | 410.4 ± 62.0 Dose (g/m^2) |
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| Ascorbic Acid 56.25 g/m^2 | 589.1 ± 135.7 Dose (g/m^2) |
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Duration of Dose in Days [Identifying Recommended Maximum Tolerated Dose (MTD)]
From enrollment through end of treatment, up to 40 weeks · Days
| Ascorbic Acid 25 g/m^2 | 235.5 ± 51.9 Days |
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| Ascorbic Acid 37.5 g/m^2 | 165.9 ± 51.4 Days |
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| Ascorbic Acid 56.25 g/m^2 | 149.0 ± 54.2 Days |
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Duration of Dose in Weeks [Identifying Recommended Maximum Tolerated Dose (MTD)]
From enrollment through end of treatment, up to 40 weeks · Weeks
| Ascorbic Acid 25 g/m^2 | 33.6 ± 7.4 Weeks |
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| Ascorbic Acid 37.5 g/m^2 | 23.7 ± 7.3 Weeks |
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| Ascorbic Acid 56.25 g/m^2 | 21.3 ± 7.7 Weeks |
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