drugset / Trial / NCT02124148
A Study of Prexasertib (LY2606368) With Chemotherapy or Targeted Agents in Participants With Advanced Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin, cetuximab, pemetrexed, fluorouracil or LY3023414) in participants with advanced cancer or cancer that has spread to another part of the body. The study has multiple parts (A, B, C, D and E). Participants will only enroll in one part.
Timeline
- Start
- 2014-06-18
- Primary completion
- 2020-02-13
- Completion
- 2020-02-13
Publications
- Moore KN, Hong DS, Patel MR, Pant S, Ulahannan SV, Jones S, Meric-Bernstam F, Wang JS, Aljumaily R, Hamilton EP, Wittchen ES, Wang X, Lin AB, Bendell JC. A Phase 1b Trial of Prexasertib in Combination with Standard-of-Care Agents in Advanced or Metastatic Cancer. Target Oncol. 2021 Sep;16(5):569-589. doi: 10.1007/s11523-021-00835-0. Epub 2021 Sep 24.
- Hong DS, Moore KN, Bendell JC, Karp DD, Wang JS, Ulahannan SV, Jones S, Wu W, Donoho GP, Ding Y, Capen A, Wang X, Bence Lin A, Patel MR. Preclinical Evaluation and Phase Ib Study of Prexasertib, a CHK1 Inhibitor, and Samotolisib (LY3023414), a Dual PI3K/mTOR Inhibitor. Clin Cancer Res. 2021 Apr 1;27(7):1864-1874. doi: 10.1158/1078-0432.CCR-20-3242. Epub 2021 Jan 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | G-CSF | Unknown | — | Subcutaneous |
| Subject | Prexasertib | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Prexasertib | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Prexasertib | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Prexasertib | Small molecule | 105 mg/m2 | Intravenous |
| Subject | Samotolisib | Small molecule | 150 mg | Oral |
| Subject | Samotolisib | Small molecule | 200 mg | Oral |
| Background | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | Pemetrexed | Small molecule | — | Intravenous |
| Background | fluorouracil | Small molecule | — | Intravenous |