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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03068351
The ClinicalTrials.gov registry entry for NCT03068351 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which daratumumab is the first listed.
NCT03068351 reports 0 study locations.
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.
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