Incurable stage IIIB/IV non-small cell lung cancer after failure of standard therapy for advanced or metastatic disease. MedDRA version: 14.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspeci
Conditions
Interventions
Product Name: 4-piperidin-1yl-but-2enoic acid[4-(3-chloro-4fluoro-phenylamino)-7-methoxyquinazol-6-yl]-amin monhyd
Product Code: PF-00299804
Pharmaceutical Form: Tablet
INN or Proposed INN: OTHER ANTI
Sponsors
WWCR, WORLDWIDE CLINICAL RESEARCH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed diagnosis of non-small cell carcinoma of the lung; Patients must have evidence of disease, but measurable disease is not mandatory. (to be considered evaluable for complete or partial response assessment, patients must have at least one measurable lesion as follows: X-ray >or= 20 mm Spiral CT scan or physical exam >or= 10 mm; Male or female, 18 years of age or older; ECOG performance status of 0, 1, 2 or 3 (patients with performance status of 3 are eligible providing that the investigator attests that the patient has a reasonable life expectancy (>or= 6 weeks); Adequate renal (Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients receiving concurrent treatment with other experimental drugs or anti-cancer therapy; Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF > 50%; Patients with untreated brain or meningeal metastases or treated with corticosteroids at least 1 week prior to randomization; Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol, including: severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren s syndrome, severe exposure keratopathy, disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis), uncontrolled inflammatory gastrointestinal diseases (Crohn's, ulcerative colitis etc), prior pneumonitis/ILD secondary to EGFR inhibitors, mean QTc > 470 msec or history of familial long QT syndrome, drugs that are highly dependent on CYP2D6 for metabolism (see § 5.2.6 of the protocol study), pregnancy or inadequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare overall survival (OS) between the 2 arms;Secondary Objective: To compare overall survival (OS) in KRAS-WT patients between the 2 arms; To compare overall survival (OS) in EGFR mutant patients between the 2 arms; To compare progression-free survival (PFS) between arms; To compare objective response rates (RR) between arms; To estimate time to response and response duration; To evaluate the nature, severity, and frequency of toxicities, between arms; To compare Quality of Life between the 2 arms; To determine the incremental cost effectiveness and cost utility ratios for PF-804; To correlate the expression of tissue and blood markers (at diagnosis) with outcomes and response.;Primary end point(s): To compare overall survival (OS) between the 2 arms. | — |
Countries
Italy
Contacts
Public ContactDirettore Generale
Dimensione Ricerca
Outcome results
None listed