Stage IV metastatic non small cell lung cancer MedDRA version: 14.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Confidential information available to regulatory authorities in the paper version only
Product Name: pentamidine bis (2-hydroxyethane sulfonate)
Product Code: OCZ103-OS
Pharmaceutical Form
Sponsors
Oncozyme Pharma Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written Informed Consent. • Males or females. • 18-75 years. • Histologically or cytologically confirmed stage IV NSCLC patients that are eligible to platinum-gemcitabine based doublet therapy. • ECOG performance 0 or 1 • One or more tumor lesions measurable by RECIST criteria on CT scan or MRI • Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the selected measurable lesions are outside the original radiation therapy port. Radiation therapy must have been completed > 4 weeks prior to study entry. • Palliative radiotherapy must have been completed > 2 weeks prior to study entry. Irradiated lesions may not serve as measurable lesions • Life expectancy of at least 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Any prior systemic therapy for recurrent or metastatic NSCLC. • Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade = 2; atrial fibrillation of any grade; QTc interval > 450 msec for males or > 470 msec for females or uncontrolled intercurrent illness, e.g. unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia < 50 bpm; a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia or family history of Long QT Syndrome). • Systolic Blood Pressure < 100 mmHg (if deemed clinically significant by the treating physician). • Inadequate baseline organ function as shown by laboratory values • To be dependent of oxygen treatment. • Active infections requiring antibiotics. • A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study. • Pregnancy or breastfeeding. All women of child-bearing potential must have a negative pregnancy test prior to first receiving protocol therapy. • Active alcohol or drug abuse. • Known or suspected allergy/hypersensitivity to any agent given in the course of this trial. • Any co-morbid condition that in the judgment of the investigator renders the subject at high risk of treatment complication or reduces the probability of assessing clinical effect. • Other malignancies diagnosed within the last 5 years with the exception of Basal Cell Carcinoma of the skin. • Patients unable to comply with the study protocol and follow-up schedule for any psychological, familial, sociological or geographical reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain a preliminary evidence of the clinical efficacy of OCZ103-OS used in combination with platinum-gemcitabine based doublet first line therapy in adult NSCLC patients, by assessing primarily Overall Response Rate (ORR), as well as Duration of Response (DR), Progression Free Survival (PFS), Overall Survival (OS), Time to progression (TP) and Time to Distant Metastasis (TDM);Secondary Objective: • To determine the clinical safety of OCZ103-OS used in combination with platinum-gemcitabine based doublet first line therapy in adult Stage IV NSCLC patients ;Primary end point(s): Overall Response rate;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival and overall survival;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Poland
Contacts
Public ContactOCZ103-206 information center
Bonne Santé
Outcome results
None listed