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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 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02603445
The ClinicalTrials.gov registry entry for NCT02603445 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Idelalisib is the first listed.
NCT02603445 reports 0 study locations.
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.
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