A double-blind placebo controlled randomized trial of PF-804 in patients with incurable stage IIIB/IV non-small cell lung cancer after failure of standard therapy for advanced or metastatic disease.

• Conditions: Incurable stage IIIB/IV non-small cell lung cancer after failure of standard therapy for advanced or metastatic disease.; MedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-016509-41-IT
• Lead Sponsor: WWCR, WORLDWIDE CLINICAL RESEARCH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-27
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 720

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 <1.5 upper limit of normal) and hepatic (total bilirubin < 1.5 upper limit of normal; ALT (SGPT) < 2.5 times the upper limit of normal. Note: If clearly attributable to liver metastasis, ALT (SGPT) values < 5 times the upper limit of normal are permitted) within 14 days prior to randomization. (if anemic, patients should be asymptomatic and should not be decompensated); Previous Therapy (see § 5.1.6 of the protocol study); Patient able and willing to complete the quality of life questionnaires; Written patient consent; Patients availability for treatment and follow-up; treatment begins within 2 working day of patient randomization.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified