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NCT02700022 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Alisertib + R-EPOCH for Treatment of Myc-Positive Aggressive B-cell Lymphomas
A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02700022 is a Phase 1 study that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 1 participants.
The verdict
NCT02700022, a Phase 1 study, was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase I/Ib study is designed to establish the safety and maximum tolerated dose (MTD, which will also be the recommended phase II dose (RP2D)) of the aurora kinase A inhibitor alisertib when combined with dose-adjusted (DA)-R-EPOCH (rituximab, etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone) in patients with CD20-positive diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma or Burkitt lymphoma positive for Myc gene rearrangement (Myc+). Filgrastim or peg-filgrastim is also included with each cycle of R-EPOCH. Once we identify the MTD, an expansion cohort limited to the Myc+ DLBCL population will be opened to further characterize clinical activity and safety. Secondary objectives include estimates of complete response rate (CR) and progression free survival (PFS). We will also explore for associations between baseline kinome signatures and/or RNA sequencing and CR, and identify differential kinome and transcriptome prior to and during treatment.
Interventions
- DRUG Alisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-10 |
| Est. Completion | 2017-08-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02700022
The ClinicalTrials.gov registry entry for NCT02700022 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alisertib is the first listed.
NCT02700022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02700022 about?
NCT02700022 is a clinical study titled "A Phase I Study of Alisertib + R-EPOCH for Treatment of Myc-Positive Aggressive B-cell Lymphomas". This phase I/Ib study is designed to establish the safety and maximum tolerated dose (MTD, which will also be the recommended phase II dose (RP2D)) of the aurora kinase A inhibitor alisertib when combined with dose-adjusted (DA)-R-EPOCH (rituximab, etoposide, doxorubicin, vincristine, cyclophosphami...
What is the current status of trial NCT02700022?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2016-10. Estimated completion is 2017-08-18.
What interventions are being tested in trial NCT02700022?
The interventions under investigation include: Alisertib (DRUG).
Who is sponsoring clinical trial NCT02700022?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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