NCT03068351

Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma

Completed Phase 1 Last updated 7 February 2020

What this trial tests

Phase 1 trial testing RO6870810 in Multiple Myeloma in 24 participants. Completed in 1 August 2019.

Timeline

26 June 2017

Primary endpoint
1 August 2019

1 August 2019

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	26 June 2017
Primary completion	1 August 2019
Estimated completion	1 August 2019
Sites	12 locations across United Kingdom, United States, Australia

Drugs / interventions tested

• RO6870810 — full drug profile →
• daratumumab (daratumumab) — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase Ib, open-label, multicenter, global study designed to assess the safety and tolerability of RO6870810 as monotherapy and in combination with daratumumab in participants with relapsed/refractory multiple myeloma. Each treatment cycle will be 21 days in length. There are two parts to this study. A dose-escalation phase (Part I) will be used to evaluate the safety and tolerability and dose limiting toxicities, and to establish the maximum tolerated dose (MTR)/optimum biological dose (OBD) of RO6870810 when given as monotherapy or in combination with daratumumab. A dose-expansion phase (Part II) will further characterize the safety, tolerability and activity of RO6870810 as monotherapy or in combination with daratumumab at the defined expansion dose-levels.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
   Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
2. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
   Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
3. Achieving clinical success with BET inhibitors as anti-cancer agents.
   Shorstova T, Foulkes WD, Witcher M. · · 2021 · cited 272× · PMID 33723398 · DOI 10.1038/s41416-021-01321-0
4. BRD4 Inhibition Is Synthetic Lethal with PARP Inhibitors through the Induction of Homologous Recombination Deficiency.
   Sun C, Yin J, Fang Y, Chen J, et al · · 2018 · cited 257× · PMID 29533782 · DOI 10.1016/j.ccell.2018.01.019
5. BET Family Protein BRD4: An Emerging Actor in NFκB Signaling in Inflammation and Cancer.
   Hajmirza A, Emadali A, Gauthier A, Casasnovas O, et al · · 2018 · cited 133× · PMID 29415456 · DOI 10.3390/biomedicines6010016
6. Epigenetics-targeted drugs: current paradigms and future challenges.
   Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
7. Bromodomain and extraterminal (BET) proteins: biological functions, diseases, and targeted therapy.
   Wang ZQ, Zhang ZC, Wu YY, Pi YN, et al · · 2023 · cited 128× · PMID 37926722 · DOI 10.1038/s41392-023-01647-6
8. Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
   Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x