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NCT02269085 · ClinicalTrials.gov registry record · Phase 1
Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02269085: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02269085 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02269085, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of carfilzomib and ibrutinib that can be given to patients with relapsed or refractory MCL. Researchers also want to learn if carfilzomib and ibrutinib can help to control the disease. This is an investigational study. Ibrutinib is FDA approved and commercially available to treat MCL and chronic lymphocytic leukemia (CLL). Carfilzomib is FDA approved and commercially available to treat certain types of multiple myeloma. Giving carfilzomib to patients with MCL is investigational. The combination of ibrutinib and carfilzomib is investigational. The study doctor can explain how the study drugs are designed to work. Up to 35 participants will be enrolled on this study. All will be enrolled at MD Anderson.
Primary Outcome
MTD is defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). DLT assessed during the first course of each cohort (28 days), and refers to a study drug related or possibly related event which meets one of the following criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Interventions
- DRUG Carfilzomib
- DRUG Ibrutinib
- BEHAVIORAL Phone Calls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-04-20 |
| Est. Completion | 2018-05-29 |
| Phase | Phase 1 |
Why NCT02269085 stopped before completion
NCT02269085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Carfilzomib is the first listed.
NCT02269085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02269085 about?
NCT02269085 is a clinical study titled "Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma". The goal of this clinical research study is to find the highest tolerable dose of carfilzomib and ibrutinib that can be given to patients with relapsed or refractory MCL. Researchers also want to learn if carfilzomib and ibrutinib can help to control the disease. This is an investigational study. ...
What is the current status of trial NCT02269085?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2015-04-20. Estimated completion is 2018-05-29.
What interventions are being tested in trial NCT02269085?
The interventions under investigation include: Carfilzomib (DRUG), Ibrutinib (DRUG), Phone Calls (BEHAVIORAL).
Who is sponsoring clinical trial NCT02269085?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02269085's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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