Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Palbociclib, palbociclib
PD 0332991 · 1 trial · 1 indication
MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (\<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever \>=38.5degrees Celsius (C); Grade \>=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 corrected QT interval (QTc) prolongation (QTc \>500 millisecond \[msec\]) in asymptomatic participants even after repeat testing to exclude confounding factors and correction of reversible causes; Delay in the administration of Cycle 2 for more than 1 week of the planned date due to platelet count \<25,000/mcL and/or ANC \<500/mcL, or due to prolonged nonhematologic toxicities of Grade \>=3; Inability to deliver at least 80 percent (%) of the planned PD 0332991 or bortezomib doses during Cycle 1 due to toxicity.
RP2D was determined based on the MTD, safety and tolerability profile of the study treatment.
OR: confirmed stringent complete response(sCR),complete response(CR),very good partial response(VGPR) or partial response(PR) as per International Myeloma Working Group Uniform Response Criteria (IMWGURC). sCR: normal serum free light chain (FLC) ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, \<5 percent (%) plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, \>= 90% reduction in serum M-protein, \<100 mg/24 hour (hr) urine M-protein. PR: \>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by \>=90% or to \<200 mg/24 hr, \>=50% decrease in difference between involved and uninvolved FLC levels if serum, urine M-protein were unmeasurable, \>= 50% reduction in plasma cells, provided baseline bone marrow plasma cell was \>=30% if serum, urine M-protein were unmeasurable and serum free light assay was unmeasureable.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bortezomib | DRUG | Escalating doses of bortezomib will be administered intravenously on Days 8, 11, 15 and 18 of a 28-day cycle (Schedule A) or of a 21-day cycle (Schedule B). The planned doses to be evaluated are 0.7, 1 and 1.3 mg/m2 in combination with PD 0332991 and dexamethasone. |
| Dexamethasone | DRUG | 20 mg, orally on Days 8, 11, 15 and 18 of a 28 day cycle (Schedule A) or of a 21-day cycle (Schedule B) in combination with PD 0332991 and bortezomib. |
| PD 0332991 | DRUG | Escalating doses of PD 0332991 will be administered orally on Days 1-21 of a 28-day cycle for Schedule A and on Days 1-12 of a 21-day cycle for Schedule B. The planned doses to be evaluated are 50, 75, 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone. |
Inclusion Criteria: * Diagnosis of symptomatic multiple myeloma as defined by International Myeloma Working Group (IMWGURC). * Phase 1: Relapsed or relapsed/refractory myeloma after at least 1 previous treatments and with a life expectancy of more than 3 months. * Phase 2: Measurable (as defined by...
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PD 0332991, also known as palbociclib, is an investigational small molecule being studied for the treatment of breast cancer, including advanced breast cancer and metastatic breast cancer. It is also being evaluated in Ewing sarcoma and other neoplasms. The drug is in Phase 2 clinical development and is not yet approved.
PD 0332991 targets cyclin-dependent kinases (CDKs), specifically CDK4 and CDK6, as indicated by its target class of -ciclib (CDK). It is a CDK4/6 inhibitor being developed as an oral therapy for hormone receptor-positive, HER2-negative breast cancer.
PD 0332991 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is also known as palbociclib and is currently in Phase 2 clinical trials for oncology indications.
PD 0332991 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The compound is being studied across multiple oncology indications, including advanced breast cancer and Ewing sarcoma, with several trials already completed.
PD 0332991 has been studied in several clinical trials, including NCT00141297, a Phase 1 study in advanced cancer; NCT01684215, a Phase 2 study in Japanese patients with advanced solid tumors or breast cancer; NCT01942135 (PALOMA-3), a Phase 3 study in metastatic breast cancer; and NCT03447132, a Phase 3 study in operable breast cancer.
Yes, PD 0332991 is the same as palbociclib. The drug is known by both names, with palbociclib being the generic name and PD 0332991 the research code. Pfizer is developing this CDK4/6 inhibitor for breast cancer and other oncology indications.