Phase 2
Completed N=69
Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer
Source: ClinicalTrials.gov NCT00768664 ↗Enrolled (actual)
69
Serious AEs
29.0%
Results posted
Feb 2021
Primary outcomePrimary: Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR) — 12.5 Percentage of participants
Summary
This study will investigate the safety and efficacy of oral PF-00299804 in patients who have not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck squamous cell cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR) |
12.5 | — |
| SECONDARY Duration of Response (DR) |
17.9 | — |
| SECONDARY Duration of Stable Disease (SD) |
14.6 | — |
| SECONDARY Progression-Free Survival (PFS) |
12.1 | — |
| SECONDARY Progression-Free Survival (PFS) at 6 Months and at 1 Year |
21.4; 2.1 | — |
| SECONDARY Overall Survival (OS) |
34.6 | — |
| SECONDARY Overall Survival at 6 Months and 1 Year |
66.5; 39.6 | — |
| SECONDARY Trough Plasma Concentrations (Ctrough) of Dacomitinib After Repeat Dosing |
64.30; 76.85; 74.50; 69.60 | — |
| SECONDARY Ctrough of Dacomitinib After Repeat Dosing In Participants Requiring Administration of Dacomitinib With a Feeding Tube |
81.30; 92.05; 129.2; 156 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube |
23.80 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) In Participants Requiring Administration of Dacomitinib With a Feeding Tube |
285.0 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube |
4.00 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) |
NA | — |
| SECONDARY Correlation Between Biomarkers Status and Best Overall Response |
0.799; 1.000; 0.840; 1.000 | — |
| SECONDARY H-Score at Baseline and Post-baseline for Paired Biopsy Biomarkers |
99.1; 123.8; 22.1; 17.9; 190.4; 184.4 | — |
| SECONDARY H-Score at Ratio to Baseline for Paired Biopsy Biomarkers |
2.0; 1.0; 1.0; 0.9; 0.7; 0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Recurrent or metastatic Squamous Cell Cancer of the Head and Neck;
- Measurable disease;
- Eastern Cooperative Oncology Group (ECOG) 0-1 in Stage 1 = first 23 patients;
- Eastern Cooperative Oncology Group (ECOG) 0-2 in Stage 2 = 33 patients;
Exclusion Criteria
- prior therapy for recurrence;
- platelets < 75,000;
- prior Epidermal Growth Factor Receptor (EGFR) therapy;
- interstitial lung disease;
- primary of nasopharynx
Data sourced from ClinicalTrials.gov (NCT00768664). 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.