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NCT02608268 · ClinicalTrials.gov registry record · Phase 1
Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 252
- Enrollment target
NCT02608268: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02608268 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 252 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (320% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02608268, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 252 participants
- Enrollment target
Study Summary
The purpose of this first-in-human study of MBG453 was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453 administered i.v. as a single agent or in combination with PDR001 or decitabine in adult patients with advanced solid tumors
Primary Outcome
Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defin
Interventions
- DRUG Decitabine
- DRUG PDR001
- DRUG MBG453
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2015-11-23 |
| Est. Completion | 2022-08-30 |
| Phase | Phase 1 |
Why NCT02608268 stopped before completion
NCT02608268 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (320% higher).
The record links to 0 conditions, and to 3 interventions - of which Decitabine is the first listed.
NCT02608268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02608268 about?
NCT02608268 is a clinical study titled "Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies". The purpose of this first-in-human study of MBG453 was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453 administered i.v. as a single agent or in combination with PDR001 or decitabine in adult patients with advanced solid tumors
What is the current status of trial NCT02608268?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 252 participants. The study started on 2015-11-23. Estimated completion is 2022-08-30.
What interventions are being tested in trial NCT02608268?
The interventions under investigation include: Decitabine (DRUG), PDR001 (DRUG), MBG453 (DRUG).
Who is sponsoring clinical trial NCT02608268?
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 NCT02608268's enrollment target sits among peer trials
252 169th of 2000 higher than 1,829 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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