ROCHE NP39403 (BET Inhibitor) : Open-label, Multicenter, Dose-escalation/Expansion Phase Ib Study to Evaluate Safety, Pharmacokinetics, and Activity of BET Inhibitor RO6870810, Given as Mono- and Combination Therapy to Patients With Advanced Multiple Myeloma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaMultiple Myeloma

Trial Overview Read MoreRead more

This phase I trial is trying to determine whether it is better to give a new drug (RO6870810) alone or in combination with a different anti-cancer drug (daratumumab) when treating patients with advanced Multiple Myeloma.
 

This trial is treating patients with Multiple Myeloma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

Open-label, Multicenter, Dose-escalation/Expansion Phase Ib Study to Evaluate Safety, Pharmacokinetics, and Activity of BET Inhibitor RO6870810, Given as Mono- and Combination Therapy to Patients With Advanced Multiple Myeloma

Commercial Sponsor

Hoffmann-La Roche

Summary

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.

Recruiting Hospitals Read MoreRead more

St Vincent's Hospital, Haematology Oncology Research
Fitzroy
Ms Lisa Demosthenous
lisa.demosthenous@svha.org.au
03 9231 3182

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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