Clinical trial · Interventional
A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer
A Phase I Clinical, Pharmacokinetic, And Pharmacodynamic Evaluation Of 2 Schedules Of Oral PD 0332991, A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer
NCT00141297CI-TRIAL-00020426completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-0332991 | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-0332991
- interventionNames
- Drug: PD-0332991
Primary outcomes (50)
- measure
- Number of Participants With Dose-Limiting Toxicities (DLT)
- timeFrame
- Baseline up to 28 days
- description
- DLT: an adverse event occurring after initiation of PD 0332991 that met any following criteria: 1) Grade 4 hematologic toxicity (platelets less than \[\<\] 25000 per microliter (mcL), absolute neutrophil count \[ANC\] \<500/mcL, hemoglobin \[Hb\] \<6.5 gram per deciliter \[g/dL\]; 2) ANC \<1000/mcL associated with documented infection or fever greater than or equal to (\>=) 38.5 degrees Celsius; 3) \>=Grade 3 non-hematologic treatment-related toxicity. In an asymptomatic participant, Grade 3 corrected QT (QTc) prolongation (\>500 millisecond) (only if persisted with repeat testing and after correction of reversible causes \[electrolyte abnormalities or hypoxia\]); and 4) Inability to receive next dose of PD 0332991 within 1 week (+/-1 day) of last dose due to lack of hematologic recovery (platelets \<50000/mcL, ANC \<1000/mcL, and Hb \<8.0 g/dL) or due to prolonged non-hematologic toxicities of \>=Grade 3 severity. Occurrence of a DLT necessitated immediate interruption of scheduled study treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced solid tumors (excluding SCLC and retinoblastoma) or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition; tumors must express Rb * Adequate blood cell counts, kidney function and liver function and and ECOG score of 0, 1, or 2. * Patients may have to have tumor biopsy before and after treatment. Exclusion Criteria: * Prior stem cell or bone marrow transplant * Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse * Active or unstable cardiac disease or history of heart attack within 6 months
References
Publications (2)
- DERIVEDMalumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602. PMID 19238148
- DERIVEDVaughn DJ, Flaherty K, Lal P, Gallagher M, O'Dwyer P, Wilner K, Chen I, Schwartz G. Treatment of growing teratoma syndrome. N Engl J Med. 2009 Jan 22;360(4):423-4. doi: 10.1056/NEJMc0808558. No abstract available. PMID 19164198