Adults 18 to 99, any sex, with Head and Neck Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)Primary· Baseline up to 18 months
Percentage of participants with best OR of confirmed CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) relative to total number of evaluable participants for response. CR defined as disappearance of all target/non-target lesions. PR defined as at least a 30 percent (%) decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR and PR) were those that persisted on a follow-up imaging assessment greater than or equal to (≥)4 weeks after the initial objective documentation of response.
Group
Value
95% CI
Dacomitinib 45 mg
12.5
5.6 – 23.5
Duration of Response (DR)Secondary· Baseline up to 18 months
Time in weeks from the first documentation of objective tumor response (CR or PR) to progression or death due to progressive disease (PD). DR was calculated as (the date of the first documentation of PD or death due to PD minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response (CR or PR).
Group
Value
95% CI
Dacomitinib 45 mg
17.9
12.6 – 20.1
Duration of Stable Disease (SD)Secondary· Baseline up to 18 months
Time in weeks from start of treatment to date of objective disease progression (based on RECIST criteria). SD defined as neither sufficient shrinkage for PR nor sufficient increase for PD, taking as a reference the smallest sum of the longest dimensions since treatment start. Participants last known to be alive, not to have started new anticancer treatment, to be progression free, and who had a baseline and at least 1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of PD. Participants who died not due to PD censored on death date.
Group
Value
95% CI
Dacomitinib 45 mg
14.6
12.0 – 24.7
Progression-Free Survival (PFS)Secondary· Baseline up to 18 months
Time in weeks from date of enrollment to first documentation of PD, death due to any cause, symptomatic deterioration, or start of secondary anticancer therapy, whichever occurred first. PFS calculated as (first event date minus enrollment date plus 1). Documentation of progression determined from objective disease assessment based on RECIST criteria. PD defined as at least a 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since treatment started or the appearance of 1 or more new lesions.
Group
Value
95% CI
Dacomitinib 45 mg
12.1
11.1 – 17.9
Progression-Free Survival (PFS) at 6 Months and at 1 YearSecondary· Baseline up to 52 weeks
Probability of being event-free (event defined as PD, death due to any cause, symptomatic deterioration, or start of secondary anticancer therapy) at 26 weeks and 52 weeks after the first dose of study treatment.
Probability of being event free at Week 26
Group
Value
95% CI
Dacomitinib 45 mg
21.4
11.4 – 33.4
Probability of being event free at Week 52
Group
Value
95% CI
Dacomitinib 45 mg
2.1
0.2 – 9.8
Overall Survival (OS)Secondary· Baseline up to 18 months
Time in weeks from the start date of enrollment to date of death due to any cause. OS was calculated as (the death date minus the enrollment date plus 1). Participants without death dates, last known to be alive were censored at last contact.
Group
Value
95% CI
Dacomitinib 45 mg
34.6
29.4 – 52.1
Overall Survival at 6 Months and 1 YearSecondary· Baseline up to Week 52
Probability of survival 26 weeks and 52 weeks after the first dose of study treatment.
Survival Probability at Week 26
Group
Value
95% CI
Dacomitinib 45 mg
66.5
53.7 – 76.5
Survival Probability at Week 52
Group
Value
95% CI
Dacomitinib 45 mg
39.6
27.6 – 51.3
Trough Plasma Concentrations (Ctrough) of Dacomitinib After Repeat DosingSecondary· Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1
Trough concentrations of dacomitinib in plasma measured as nanograms per milliliter (ng/mL).
Cycle 1 Day 8
Group
Value
95% CI
Dacomitinib 45 mg
64.30
0.000 – 118
Cycle 2 Day 1
Group
Value
95% CI
Dacomitinib 45 mg
76.85
7.67 – 244
Cycle 3 Day 1
Group
Value
95% CI
Dacomitinib 45 mg
74.50
21.6 – 248
Cycle 4 Day 1
Group
Value
95% CI
Dacomitinib 45 mg
69.60
12.1 – 191
Ctrough of Dacomitinib After Repeat Dosing In Participants Requiring Administration of Dacomitinib With a Feeding TubeSecondary· Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1
Cycle 1 Day 8
Group
Value
95% CI
Dacomitinib 45 mg
81.30
46.1 – 105
Cycle 2 Day 1
Group
Value
95% CI
Dacomitinib 45 mg
92.05
64.3 – 130
Cycle 3 Day 1
Group
Value
95% CI
Dacomitinib 45 mg
129.2
95.3 – 163
Cycle 4 Day 1
Group
Value
95% CI
Dacomitinib 45 mg
156
156 – 156
Maximum Observed Plasma Concentration (Cmax) In Participants Requiring Administration of Dacomitinib With a Feeding TubeSecondary· Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
Group
Value
95% CI
Dacomitinib 45 mg
23.80
23.8 – 23.8
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) In Participants Requiring Administration of Dacomitinib With a Feeding TubeSecondary· Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Group
Value
95% CI
Dacomitinib 45 mg
285.0
285 – 285
Time to Reach Maximum Observed Plasma Concentration (Tmax) In Participants Requiring Administration of Dacomitinib With a Feeding TubeSecondary· Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
Group
Value
95% CI
Dacomitinib 45 mg
4.00
4.00 – 4.00
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dacomitinib 45 mg
Serious: 20/69 (29%)
Deaths: —
Serious adverse events (34 terms)
Reaction
System
Dacomitinib 45 mg
Diarrhoea
Gastrointestinal disorders
—
Disease progression
General disorders
—
Vomiting
Gastrointestinal disorders
—
Dehydration
Metabolism and nutrition disorders
—
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
—
Anaemia
Blood and lymphatic system disorders
—
Angina pectoris
Cardiac disorders
—
Atrial fibrillation
Cardiac disorders
—
Cardio-respiratory arrest
Cardiac disorders
—
Dysphagia
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Chest pain
General disorders
—
Brain abscess
Infections and infestations
—
Cellulitis
Infections and infestations
—
Pneumonia
Infections and infestations
—
Sepsis
Infections and infestations
—
Septic shock
Infections and infestations
—
Pelvic fracture
Injury, poisoning and procedural complications
—
Blood creatinine increased
Investigations
—
Decreased appetite
Metabolism and nutrition disorders
—
Hypercalcaemia
Metabolism and nutrition disorders
—
Hyperglycaemia
Metabolism and nutrition disorders
—
Hyponatraemia
Metabolism and nutrition disorders
—
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Cerebral infarction
Nervous system disorders
—
Other adverse events (189 terms — click to expand)
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01000025 — PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Meta
· Phase 3
· completed
NCT00728390 — A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks
· Phase 1
· completed
NCT00548093 — PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erl
· Phase 2
· completed
NCT00553254 — Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer
· Phase 2
· completed
NCT00225121 — Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumo
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 9 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00768664.