Phase 2
N=119
Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
Carcinoma, Non-small Cell
Bottom Line
View on ClinicalTrials.gov: NCT00818441 ↗Enrolled (actual)
119
Serious AEs
31.9%
Results posted
Jun 2016
Primary outcome: Primary: Progression-Free Survival (PFS) at Month 4: Cohort A — 76.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dacomitinib (PF-00299804) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) at Month 4: Cohort A |
76.9 | — |
| SECONDARY Progression-Free Survival (PFS) at Month 4: Cohort B |
24.9 | — |
| SECONDARY Progression-Free Survival (PFS) |
11.5; 2.6 | — |
| SECONDARY Best Overall Response (BOR) |
1; 0; 47; 3; 27; 11 | — |
| SECONDARY Duration of Response (DR) |
12.9; 12.4 | — |
| SECONDARY Overall Survival (OS) |
29.5; 9.3 | — |
| SECONDARY European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score |
22; 3; 21; 11; 39; 15 | — |
| SECONDARY European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score |
21; 5; 16; 8; 47; 16 | — |
| SECONDARY Trough Plasma Concentrations (Ctrough) of Dacomitinib |
48.30; 52.04; 56.61; NA; 76.50; 74.22 | — |
Summary
This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.
Eligibility Criteria
Inclusion Criteria
- Advanced adenocarcinoma of lung, measurable disease
- Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
- patients with known EGFR activating mutation regardless of smoking status
- ECOG(Eastern Cooperative Oncology Group) 0-1.
Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy
Exclusion Criteria
- Active brain metastases
- Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
- known EGFR wild type NSCLC
Data sourced from ClinicalTrials.gov (NCT00818441). 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.