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NCT01111188 · ClinicalTrials.gov registry record · Phase 1
Trial of PD 0332991 Plus Bortezomib in Patients With Relapsed Mantle Cell Lymphoma
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01111188 is a Phase 1 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 20 participants.
The verdict
NCT01111188, a Phase 1 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Mantle cell lymphoma (MCL) is characterized by cell cycle dysregulation. PD 0332991 is a cyclin-dependent kinase 4 and 6 inhibitor capable of inhibiting cell cycling of MCL. A phase I study has demonstrated the safety and anti-lymphoma activity of PD 0332991. Bortezomib is a first generation proteasome inhibitor approved for treatment of patients with recurrent MCL. Preclinical data suggests that PD 0332991 and bortezomib may act synergistically in MCL. PD 0332991 will be administered continuously for 12 days followed by a 9 day period without treatment. Bortezomib will be administered by intravenous bolus on days 8, 11, 15, and 18 of each cycle. One cycle is defined as three weeks. A maximum of ten cycles will be administered.
Interventions
- DRUG bortezomib
- DRUG PD 0332991
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-08-23 |
| Est. Completion | 2019-04-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01111188
The ClinicalTrials.gov registry entry for NCT01111188 describes a study currently listed as terminated, 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 Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which bortezomib is the first listed.
NCT01111188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01111188 about?
NCT01111188 is a clinical study titled "Trial of PD 0332991 Plus Bortezomib in Patients With Relapsed Mantle Cell Lymphoma". Mantle cell lymphoma (MCL) is characterized by cell cycle dysregulation. PD 0332991 is a cyclin-dependent kinase 4 and 6 inhibitor capable of inhibiting cell cycling of MCL. A phase I study has demonstrated the safety and anti-lymphoma activity of PD 0332991. Bortezomib is a first generation proteas...
What is the current status of trial NCT01111188?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-08-23. Estimated completion is 2019-04-12.
What interventions are being tested in trial NCT01111188?
The interventions under investigation include: bortezomib (DRUG), PD 0332991 (DRUG).
Who is sponsoring clinical trial NCT01111188?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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