Phase 2
Completed N=125
Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
Source: ClinicalTrials.gov NCT02499120 ↗Enrolled (actual)
125
Serious AEs
35.5%
Results posted
Sep 2019
Primary outcomePrimary: Overall Survival (OS) — 9.7; 7.8 months — p=0.1800
Summary
The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
9.7; 7.8 | 0.1800 |
| SECONDARY Progression Free Survival (PFS) |
3.9; 4.6 | 0.4953 |
| SECONDARY Percentage of Participants With Objective Response (OR) |
27.7; 25.0 | — |
| SECONDARY Percentage of Participants With Clinical Benefit Response (CBR) |
36.9; 36.7 | — |
| SECONDARY Duration of Response (DR) |
7.6; 7.4 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events(TEAEs) |
61; 56; 58; 48; 25; 19 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
61; 55 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) |
2.82; 2.69; 0.74; -0.46; -0.41; -1.60 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35) |
-3.57; -0.41; -4.34; -1.47; -1.58; -1.88 | — |
| SECONDARY Summary of PFS and OS for P16 Negative (%Positive Tumor Cells < 70%) |
3.7; 5.0; 9.9; 8.0 | — |
| SECONDARY Summary of PFS and OS Based on Investigator Assessment by Rb Expression >= 1% |
3.9; 4.6; 10.5; 7.8 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) and Within-participant Mean Steady-state Pre-dose Concentration (WPM-Ctrough) at Steady State for Palbociblib |
69.8; 67.8; 71.6 | — |
| SECONDARY Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab |
39706.4; 42914.1; 51005.3; 52995.7; 45605.9; 46796.5 | — |
Eligibility Criteria
Key Inclusion Criteria
- Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy.
- Measurable disease as defined per RECIST v. 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented.
- HPV- negative SCCHN tumor as determined per institutional standard (eg, p16 IHC; multiplex nucleic acid sequence based amplification [NASBA] or other polymerase chain reaction [PCR]-based assays).
- Documented progressive disease according to RECIST v1.1 (Appendix 2) following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for R/M disease (min. 50 mg/m2 for cisplatin, minimum area under the curve [AUC] > 4 for carboplatin).
- Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides]), which will be used for centralized, retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
Key Exclusion Criteria
- Prior nasopharyngeal cancer, salivary gland or sinus tumors.
- More than one chemotherapeutic regimen given for R/M disease. Prior treatment with immunotherapy is allowed.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
- Progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced SCCHN.
- Difficulty swallowing capsules.
- Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during curative radiotherapy)
Data sourced from ClinicalTrials.gov (NCT02499120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.