Non-small cell lung cancer (NSCLC) MedDRA version: 8.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
Conditions
Interventions
Product Name: Onconase
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Ranpirnase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Sponsors
Alfacell Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed NSCLC of stages IIIB and IV Informed written consent WBC >=3000 cells/mme3, ANC >= 1,500 cells/mme3, platelets >=100,000/mme3 Coagulation profil within normal limits Normal creatinine, creatinine clearance >=60mL/min/1.73me2 This is valid for part I and II Part I: relapsed or refractory patients with at least 2 prior regimens Part II: refractory patients with only 1 prior regimen 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Chemotherapy or radiation within 4 weeks prior to entry Surgery within 2 weeks prior to entry NYHA III or IV Serious infections Pregnant or lactating women Uncontrolled diabetes mellitus Abnormal electrolytes, other metabolic disorders, like metabolic acidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of appropriate dose, part I Objective responses (CR, PR) in part II;Secondary Objective: Safety parameters (laboratory and clinical) in part I and II;Primary end point(s): Appropriate dosing schedule for phase II, part 1 Response rate (CR, PR, MR, NC, PD), time to progression, part II | — |
Countries
Germany
Outcome results
None listed