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NCT02603445 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCL
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02603445: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02603445 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02603445, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a phase Ib multi-center, open-label study: escalation part followed by expansion part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety and tolerability of BCL201 combined with idelalisib in patients with FL and MCL. Approximately 65 patients are to be enrolled. The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib. In addition Bayesian regression models will be used to estimate the dose-exposure relationships for both BCL201 and idelalisib in order to guide the escalation steps. A Bayesian method for the expansion part will be used for the primary activity objective. The study data will be analyzed and reported based on all patients' data of the escalation and expansion part.
Primary Outcome
Characterized by Frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as electrocardiogram (ECG) changes
Interventions
- DRUG Idelalisib
- DRUG BCL201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-11-16 |
| Est. Completion | 2018-07-10 |
| Phase | Phase 1 |
What the finished NCT02603445 record still lists
NCT02603445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Idelalisib is the first listed.
NCT02603445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02603445 about?
NCT02603445 is a clinical study titled "Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCL". This is a phase Ib multi-center, open-label study: escalation part followed by expansion part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety and tolerability of BCL201 combined with idelalisib in patients with FL and MCL. Approximately 65 patients are to be e...
What is the current status of trial NCT02603445?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2015-11-16. Estimated completion is 2018-07-10.
What interventions are being tested in trial NCT02603445?
The interventions under investigation include: Idelalisib (DRUG), BCL201 (DRUG).
Who is sponsoring clinical trial NCT02603445?
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 NCT02603445's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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