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NCT03068351 · ClinicalTrials.gov registry record · Phase 1
Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03068351: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03068351 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03068351, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
DLTs are defined as the toxicities known and expected of RO6870810 and daratumumab that occur during a DLT assessment window of 21 days from the first administration of RO6870810 or study combination treatments, and are considered by the Investigator to be related to study treatment. DLTs are defined at specific severity levels for each term and include, but are not limited to the following Common Terminology Criteria for Adverse Events (CTCAE) terms: neutropenia, febrile neutropenia, thrombocyt
Interventions
- BIOLOGICAL daratumumab
- DRUG RO6870810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2019-08-01 |
| Phase | Phase 1 |
What the finished NCT03068351 record still lists
NCT03068351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which daratumumab is the first listed.
NCT03068351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03068351 about?
NCT03068351 is a clinical study titled "Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma". 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 t...
What is the current status of trial NCT03068351?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-06-26. Estimated completion is 2019-08-01.
What interventions are being tested in trial NCT03068351?
The interventions under investigation include: daratumumab (BIOLOGICAL), RO6870810 (DRUG).
Who is sponsoring clinical trial NCT03068351?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03068351's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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