Secondary prophylaxis for the treatment of chemotherapy induced thrombocytopenia (CIT) in subjects with Non-Small Cell Lung Cancer (NSCLC) receiving myelosuppressive chemotherapy. MedDRA version: 8.1 Level: LLT Classification code 10023780 Term: Large cell lung cancer stage IV
Conditions
Interventions
Product Name: AMG 531
Product Code: AMG 531
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: AMG 531
Concentration unit: µg microgram(s)
Concentration type: equ
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease related: • Histologically or cytologically confirmed locally advanced or metastatic stage IIIB (not amenable to surgery or radiotherapy with a curable intent) or stage IV NSCLC who will be receiving Q21 day gemcitabine / carboplatin or gemcitabine / cisplatin • Life expectancy = 12 weeks at the time of screening • Thrombocytopenia as evidenced by a platelet count 1,000/µL, Hgb > 9.5 g/dL, and platelet count > 100 x 109/L on Day 1 of the first on study chemotherapy treatment cycle Demographic • Subject must be = 18 years of age • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance Laboratory • Adequate liver function; AST and ALT 5 x ULN); and serum bilirubin = 1.5 times ULN (except for subjects with a confirmed diagnosis of Gilbert’s Syndrome) • Adequate renal function; serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease Related • Receipt of >1 prior systemic chemotherapy regimen • Sepsis, disseminated intravascular coagulation, or any other condition (i.e. ITP, TTP, HUS) that may have exacerbated thrombocytopenia • History of unstable angina, CHF {NYHA >class II, see Appendix F}, uncontrolled hypertension {diastolic>100mmHG}, uncontrolled cardiac arrhythmia, or recent (within 1 year of screening) MI • History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening • History of pulmonary embolism or other venous thrombosis within 1 year of screening (except for catheter-related clots) Medications • Receipt of any nitrosourea (BCNU, CCNU) or mitomycin-C within 6 weeks of screening • Receipt of any thrombopoietic growth factor or related substance • Receipt of granulocyte macrophage colony stimulating factor (GM-CSF) within the last 4 weeks prior to screening • Receipt of any experimental therapy within 4 weeks prior to screening • Receipt of a bone marrow or peripheral blood stem cell infusion (within 1 year of screening) General • Pregnant or breastfeeding • Reproductive potential and not using adequate contraceptive precautions in the judgment of the investigator • Hypersensitivity to any recombinant E. Coli-derived product • Inability to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of AMG 531 in treating CIT in NSCLC subjects receiving myelosuppressive chemotherapy.;Secondary Objective: To evaluate the efficacy of AMG 531 (dose and schedule) in treating CIT in NSCLC subjects receiving myelosuppressive chemotherapy.;Primary end point(s): Primary Endpoint • The incidence of adverse events (AEs) and the incidence of anti-AMG 531antibody formation by treatment group Secondary Endpoints: • The incidence of subjects in each treatment group who experience grade 3 or 4 thrombocytopenia (< 50 x 109/L) during the first on study chemotherapy treatment cycle • The incidence of subjects in each treatment group who are administered platelet transfusions during the first on study chemotherapy treatment cycle • The platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of the next cycle) by treatment group • The incidence of subjects in each treatment group that require gemcitabine dose reduction on Day 8 of the first on study chemotherapy treatment cycle • The duration of grade 3 or 4 thrombocytopenia experienced during the first on study chemotherapy treatment cycle by treatment group Exploratory Endpoints • The number of days required for the platelet count to recover from nadir to 100 x 109/L during the first on study chemotherapy treatment cycle in each treatment group • The number of days between Day 1 of the first on study cycle to recovery of platelet count to 100 x 109/L following the nadir within each treatment group • The total incidence of grade 3 and/or 4 thrombocytopenia in each treatment group during the study • The average duration of grade 3 or 4 thrombocytopenia per cycle for each subject in each treatment group during the study • The average platelet nadir per cycle for each subject in each treatment group during the study • The total incidence of platelet transfusion in each treatment group • The incidence of subjects with chemotherapy dose delay and/or dose reduc | — |
Countries
Austria, Hungary, Ireland, Italy, Portugal
Outcome results
None listed