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

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT03068351
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO6870810 — DRUG
    RO6870810 will be administered subcutaneously (SC) at ascending-dose levels (from 0.30 milligrams/kilogram \[mg/kg\] to 0.65 mg/kg). In Cycle 1, RO6870810 will be given on Day 1 (omitted on Day 2) and then every day from Day 3 through to Day 15. Starting at Cycle 2, it will be given every day from Day 1 to Day 14 of each 21-day cycle. In the first combination therapy cohort RO6870810 will be administered at one dose-level below the maximum tolerated dose (MTD).
  • daratumumab — BIOLOGICAL
    Daratumumab will be administered intravenously (IV) at a dose of 16 milligrams/kilogram (mg/kg) of body weight weekly for the first 8 weeks, every two weeks for the following 16 weeks, and every four weeks thereafter, until disease progression.

Study Details

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.

Key Dates

Start date
Jun 26, 2017
Status verified
Feb 2020
Primary completion
Aug 1, 2019
Completion
Aug 1, 2019

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: RO6870810
    Participants will be administered RO6870810 monotherapy at ascending-dose levels during the dose escalation phase followed by an expansion phase during which RO6870810 will be administered as monotherapy at the recommended dose. Participants will continue to receive study drug as long as they experience clinical benefit in the opinion of the Investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression, as determined by the Investigator after an integrated assessment of IMWG response criteria, biopsies/aspirate (if applicable), and clinical status, or withdrawal of consent.
  • Experimental: RO6870810 + Daratumumab
    Participants will be administered RO6870810 at ascending-dose levels in combination with daratumumab at the recommended dose during the dose escalation phase followed by an expansion phase during which both RO6870810 and daratumumab will be administered each at their recommended dose. Participants will continue to receive the study drugs as long as they experience clinical benefit in the opinion of the Investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression, as determined by the Investigator after an integrated assessment of IMWG response criteria, biopsies/aspirate (if applicable), and clinical status, or withdrawal of consent.

Primary Outcome Measure

Number of Dose-Limiting Toxicities (DLTs) [ Time Frame: From first drug administration to end of dose-escalation phase (up to approximately 1 year) ]

Locations (8)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Stanford Cancer CenterStanfordCalifornia94305-5820-
Mayo ClinicJacksonvilleFlorida32224-
Emory Uni - Winship Cancer Center; Hematology/OncologyAtlantaGeorgia30322-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Mount Sinai - PRIME; Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Duke Clin Rsch InstituteDurhamNorth Carolina27710-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAStanford Cancer Center· Stanford, CAMayo Clinic· Jacksonville, FLEmory Uni - Winship Cancer Center; Hematology/Oncology· Atlanta, GADana Farber Cancer Institute· Boston, MAMount Sinai - PRIME; Icahn School of Medicine at Mount Sinai· New York, NY

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