drugset / Trial / NCT03177187
Combination Study of AZD5069 and Enzalutamide.
Phase 1/2
Terminated
30 enrolled
Institute of Cancer Research, United Kingdom
Astellas Pharma Inc · collabAstraZeneca · collabProstate Cancer UK · collab
Non-randomizedParallel-groupOpen-labelHealth-services research
Summary
ACE is a multi-centre proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069, administered in combination with enzalutamide, in patients with metastatic castration resistant prostate cancer(mCRPC). The investigators will be investigating the safety and toxicity of the combination.
Timeline
- Start
- 2017-11-13
- Primary completion
- 2022-09-15
- Completion
- 2022-11-16
Publications
- Results Guo C, Sharp A, Gurel B, Crespo M, Figueiredo I, Jain S, Vogl U, Rekowski J, Rouhifard M, Gallagher L, Yuan W, Carreira S, Chandran K, Paschalis A, Colombo I, Stathis A, Bertan C, Seed G, Goodall J, Raynaud F, Ruddle R, Swales KE, Malia J, Bogdan D, Tiu C, Caldwell R, Aversa C, Ferreira A, Neeb A, Tunariu N, Westaby D, Carmichael J, Fenor de la Maza MD, Yap C, Matthews R, Badham H, Prout T, Turner A, Parmar M, Tovey H, Riisnaes R, Flohr P, Gil J, Waugh D, Decordova S, Schlag A, Cali B, Alimonti A, de Bono JS. Targeting myeloid chemotaxis to reverse prostate cancer therapy resistance. Nature. 2023 Nov;623(7989):1053-1061. doi: 10.1038/s41586-023-06696-z. Epub 2023 Oct 16.
- Armstrong AJ, Geva R, Chung HC, Lemech C, Miller WH Jr, Hansen AR, Lee JS, Tsai F, Solomon BJ, Kim TM, Rolfo C, Giranda V, Ren Y, Liu F, Kandala B, Freshwater T, Wang JS. CXCR2 antagonist navarixin in combination with pembrolizumab in select advanced solid tumors: a phase 2 randomized trial. Invest New Drugs. 2024 Feb;42(1):145-159. doi: 10.1007/s10637-023-01410-2. Epub 2024 Feb 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AZD5069 | Small molecule | 40 mg | Oral |
| Subject | AZD5069 | Small molecule | 80 mg | Oral |
| Subject | AZD5069 | Small molecule | 120 mg | Oral |
| Subject | AZD5069 | Small molecule | 160 mg | Oral |
| Subject | AZD5069 | Small molecule | 240 mg | Oral |
| Subject | AZD5069 | Small molecule | 320 mg | Oral |
| Background | Enzalutamide | Other / unclassified | 160 mg | Oral |