Confirmed locally advanced or metastatic Non-Small Cell Lung Cancer, which is stage IIIB or stage IV disease not curable with surgery or radiotherapy at study entry. MedDRA version: 8.0 Level: LLT Classification code 10029514
Conditions
Interventions
Product Name: YM155
Product Code: YM155
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: YM 155
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: eq
Sponsors
Yamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V. by August 2005)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient of ³18 years, 2. Histologically or cytologically confirmed locally advanced or metastatic Non-Small Cell Lung Cancer, which is stage IIIB or stage IV disease not curable with surgery or radiotherapy at study entry, 3. Patient has recurrent or refractory disease following 1 or 2 prior chemotherapy regimens, one of which must have included a platinum agent (unless contraindicated). In addition, EGFR TKI therapy is allowed, 4. Patient has measurable disease, defined as at least 1 target lesion according to the RECIST criteria (see definition in Appendix 4), 5. ECOG performance status 0-2, 6. Life expectancy greater than 12 weeks, 7. Willingness to comply with all procedures and assessments, 8. Written informed consent has been obtained. 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: 1. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 4 weeks prior to the start of treatment (6 weeks for nitrosoureas or mitomycin C, or other agents known to cause prolonged marrow suppression, and 2 weeks for palliative external radiotherapy) or planned to be delivered during the study, 2. Unresolved chronic non-hematological toxicity higher than NCI-CTC grade 2 (excluding cases of alopecia), 3. Extensive radiation therapy within 4 weeks prior to the start of treatment, 4. Participated in a clinical study involving an investigational drug or device within 4 weeks prior to the start of treatment, 5. Has metastases to the brain unless the metastases have been appropriately treated with radiation therapy and the patient is neurologically stable and does not require steroids, 6. Has inadequate bone marrow, renal, and hepatic function as evidenced by: a. Absolute neutrophil count (ANC) =1500/mm3 and platelet count =100000/mm3, b. Serum creatinine above the upper limit of normal (ULN) or calculated creatinine clearance <60 mL/min at screening, c. Total bilirubin =1.5 times the upper limit of normal (ULN) NCI CTC grade 1, d. Alanine transaminase (ALT) and aspartate transaminase (AST) =2.5 times ULN (NCI CTCAE Grade 1); if the patient has documented liver metastases and/or hepatoma, ALT and AST =5 times the ULN. 7. History of other malignancies within past 5 years with the exception of non melanoma skin cancer and cervical carcinoma in situ, 8. Has a known or suspected diagnosis of hepatitis B surface antigen (HbsAg) or hepatitis C antibody, 9. Has a known or suspected diagnosis of Acquired Immune Deficiency Syndrome (AIDS) or tested seropositive for human immunodeficiency virus (HIV) antibody or antigen at screening, 10. Had major surgery within the past 21 days prior to the start of treatment, 11. Uncontrolled intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements, 12. Any clinical condition, which, in the opinion of the investigator, would not allow safe conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of YM155 based on objective tumor response rate (CR+PR) in patients with measurable disease based on RECIST criteria;Secondary Objective: 1.To evaluate the efficacy of YM155 on secondary endpoints: a. The tumor response rate (CR+PR) in patients who have received at least 2 cycles of treatment (modified FAS) b. The tumor response rate (CR+PR) in patients who meet the per protocol criteria (PPS) c. The tumor response rate (CR+PR) after 2, 4 or 6 cycles of treatment. d. At each time point (2, 4 or 6 cycles) the percentage of patients with CR, PR, SD and PD e. The duration of overall response f. The duration of stable disease g. Time to overall response (CR+PR) h. Progression-free survival i. Overall survival 2. To evaluate the safety and tolerability of YM155. 3. To assess population pharmacokinetics of YM155;Primary end point(s): The primary variable is the tumor response rate, defined as the percentage of patients with a confirmed tumor response (complete or partial response), in all eligible patients who started treatment with study drug (FAS). The best response for up to 6 cycles of therapy will be used to define the response for an individual subject. Tumor response definitions are according to the RECIST criteria. | — |
Countries
Czech Republic, Germany, United Kingdom
Outcome results
None listed