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NCT03400176 · ClinicalTrials.gov registry record · Phase 1
VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT03400176: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT03400176 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03400176, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. This study had two parts, a dose escalation part and a dose expansion part.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of treatment with the combination of VAY736 and ibrutinib and meets the criteria defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE
Interventions
- DRUG ibrutinib
- DRUG VAY736
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-04-09 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 1 |
Why NCT03400176 stopped before completion
NCT03400176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which ibrutinib is the first listed.
NCT03400176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03400176 about?
NCT03400176 is a clinical study titled "VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib". Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. This study had two parts, a dose escalation part and a do...
What is the current status of trial NCT03400176?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2018-04-09. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT03400176?
The interventions under investigation include: ibrutinib (DRUG), VAY736 (DRUG).
Who is sponsoring clinical trial NCT03400176?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03400176's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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