drugset / Trial / NCT03641547
M6620 Plus Standard Treatment in Oesophageal and Other Cancer
NaSingle-groupOpen-labelTreatment
Summary
This Phase I study will test the combination of a novel ATR inhibitor (M6620) with chemoradiotherapy in oesophageal cancer; utilizing three experimental cohorts (Stage A1, A2 and B).
Timeline
- Start
- 2018-12-04
- Primary completion
- 2022-04-04
- Completion
- 2022-04-04
Publications
- Javed SR, Lord S, El Badri S, Harman R, Holmes J, Kamzi F, Maughan T, McIntosh D, Mukherjee S, Ooms A, Radhakrishna G, Shaw P, Hawkins MA. CHARIOT: a phase I study of berzosertib with chemoradiotherapy in oesophageal and other solid cancers using time to event continual reassessment method. Br J Cancer. 2024 Feb;130(3):467-475. doi: 10.1038/s41416-023-02542-1. Epub 2023 Dec 21.
- van Werkhoven E, Hinsley S, Frangou E, Holmes J, de Haan R, Hawkins M, Brown S, Love SB. Practicalities in running early-phase trials using the time-to-event continual reassessment method (TiTE-CRM) for interventions with long toxicity periods using two radiotherapy oncology trials as examples. BMC Med Res Methodol. 2020 Jun 22;20(1):162. doi: 10.1186/s12874-020-01012-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Berzosertib | Small molecule | 90 mg/m2 | — |
| Subject | Berzosertib | Small molecule | 140 mg/m2 | — |
| Subject | Berzosertib | Small molecule | 240 mg/m2 | — |
| Background | Capecitabine | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |