drugset / Trial / NCT01111188
Trial of PD 0332991 Plus Bortezomib in Patients With Relapsed Mantle Cell Lymphoma
Phase 1
Terminated
20 enrolled
Weill Medical College of Cornell University
Millennium Pharmaceuticals, Inc. · collabPfizer · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-08-23
- Primary completion
- 2013-02-26
- Completion
- 2019-04-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 0.7 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Palbociclib | Small molecule | 50 mg | Oral |
| Subject | Palbociclib | Small molecule | 75 mg | Oral |
| Subject | Palbociclib | Small molecule | 100 mg | Oral |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |