Phase 2
Completed N=41
A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01858389 ↗Enrolled (actual)
41
Serious AEs
39.5%
Results posted
Jul 2017
Primary outcomePrimary: Best Overall Response (BOR) in Participants With T790M Mutation — 0; 1; 7; 6 Participants
Summary
This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response (BOR) in Participants With T790M Mutation |
0; 1; 7; 6; 2 | — |
| PRIMARY Objective Response Rate (ORR) in Participants With T790M Mutation |
6.3 | — |
| SECONDARY Disease Control Rate (DCR) for Participants With T790M Mutation |
50 | — |
| SECONDARY Duration of Response in Participants With T790M Mutation |
2.83 | — |
| SECONDARY Progression-free Survival |
2.3; 1.6 | — |
| SECONDARY Progression-free Survival at 4 Months |
37.5; 25.3 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for Dacomitinib and PF-05199265 |
96.76; 8.45 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) for Dacomitinib and PF-05199265 |
6.07; 5.58 | — |
| SECONDARY Changes From Time-matched Baseline in Adjusted Fridericia Corrected QT Interval (QTcF) on Echocardiogram (ECG) |
1.7; 4.4; 0.4; -0.4; 0.1; 0.5 | — |
Eligibility Criteria
Inclusion Criteria
- Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
- Evidence of T790M mutation to enroll in Cohort A.
- Evidence of measurable disease by radiographic technique.
- Adequate organ function.
Exclusion Criteria
- Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression.
- Symptomatic brain metastases.
- Uncontrolled or significant cardiovascular disease.
- Pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT01858389). 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.