Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM)
Phase 1/2
Completed
NCT03410030
| Condition | Pancreatic Cancer, Pancreas Cancer, Pancreatic Adenocarcinoma Resectable, Pancreatic Ductal Adenocarcinoma |
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| Phase | Phase 1/2 |
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| Sponsor | HonorHealth Research Institute |
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| Status | Completed |
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| Enrollment | 17 participants |
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| Interventions | 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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| Start date | Dec 15, 2017 |
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| Completion date | Sep 14, 2021 |
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| Results posted | Jul 23, 2026 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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