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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: Clinical Trial Phase 1 study, sponsored by Weill Medical College of Cornell University.
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, 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
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.
Primary Outcome
MTD will be determined by occurrence of Dose Limiting Toxicities during the first cycle: * Any treatment-related grade 3 or 4 non-hematologic toxicity (except alopecia) * Delay in the administration of cycle 2 by more than one week due to treatment-related grade 4 neutropenia or thrombocytopenia or treatment-related grade 3-4 non-hematologic toxicity.
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 |
Why NCT01111188 stopped before completion
NCT01111188 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 bortezomib is the first listed.
NCT01111188 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01111188'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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