drugset / Trial / NCT02391480
A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.
Timeline
- Start
- 2015-04-14
- Primary completion
- 2019-07-05
- Completion
- 2019-07-05
Publications
- Results Piha-Paul SA, Sachdev JC, Barve M, LoRusso P, Szmulewitz R, Patel SP, Lara PN Jr, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors. Clin Cancer Res. 2019 Nov 1;25(21):6309-6319. doi: 10.1158/1078-0432.CCR-19-0578. Epub 2019 Aug 16.
- Borthakur G, Odenike O, Aldoss I, Rizzieri DA, Prebet T, Chen C, Popovic R, Modi DA, Joshi RH, Wolff JE, Jonas BA. A phase 1 study of the pan-bromodomain and extraterminal inhibitor mivebresib (ABBV-075) alone or in combination with venetoclax in patients with relapsed/refractory acute myeloid leukemia. Cancer. 2021 Aug 15;127(16):2943-2953. doi: 10.1002/cncr.33590. Epub 2021 May 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mivebresib | Small molecule | 1.5 mg | Oral |
| Subject | Mivebresib | Small molecule | 2 mg | Oral |
| Subject | Mivebresib | Small molecule | 2.5 mg | Oral |
| Subject | Mivebresib | Small molecule | 3 mg | Oral |
| Subject | Mivebresib | Small molecule | 4 mg | Oral |
| Subject | Mivebresib | Small molecule | 4.5 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Subject | Venetoclax | Small molecule | 800 mg | — |