Protocol Title Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Advanced Non-Small Cell Lung Cancer Already Receiving Gemcitabine and Platinum - AMG 531 20050154
- Conditions
- secondary therapy for the treatment of Chemotherapy-Induced Thrombocytopenia CIT in Subjects With Advanced Non-Small Cell Lung Cancer NSCLC Already Receiving mielosoppressive chemotherapy.MedDRA version: 9.1Level: LLTClassification code 10043554Term: Thrombocytopenia
- Registration Number
- EUCTR2006-003699-36-IT
- Lead Sponsor
- AMGEN S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 95
Written informed consent to participate in the study Age 18 years 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 Q21day gemcitabine / carboplatin or gemcitabine / cisplatin Life expectancy 8805; 12 weeks at the time of screening Thrombocytopenia as evidenced by a platelet count 50 x 109/L during the qualifying cycle of chemotherapy, OR platelet count 100 x 109/L on Day 22 of the qualifying cycle for eligibility inclusion ability to receive the same dose of chemotherapy on study , this criteria ensures that the subject must be dose delayed for platelet recovery Ability to receive the same dose and schedule of chemotherapy during the first on study treatment cycle as was given in the qualifying cycle except Day 8 gemcitabine ANC 1,000/ 956;L, Hgb 9.5 g/dL, and platelet count 100 x 109/L on Day 1 of the first on study chemotherapy treatment cycle1 Adequate liver function; AST and ALT 3.0 x ULN except for subjects with liver mets which will be excluded if 5 x ULN ; and serum bilirubin 8804; 1.5 times ULN except for subjects with a confirmed diagnosis of Gilbert s Syndrome Adequate renal function serum creatinine 1.5 x ULN Eastern Cooperative Oncology Group ECOG performance status of 0 to 2
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
Receipt of 1 prior systemic chemotherapy regimen Sepsis, disseminated intravascular coagulation, or any other condition i.e. immune thrombocytopenic purpura ITP , thrombotic thrombocytopenic purpura TTP , hemolytic uremic syndrome HUS that may have exacerbated thrombocytopenia History of unstable angina, CHF NYHA class II , uncontrolled hypertension diastolic 100mmHG , uncontrolled cardiac arrhythmia, or recent within 1 year of screening myocardial infarction 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 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 the last 4 weeks prior to screening Receipt of a bone marrow or peripheral blood stem cell infusion within 1 year of screening Pregnant or breast feeding 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective To evaluate the safety of AMG 531 in treating CIT in NSCLC subjects receiving myelosuppressive chemotherapy.;Secondary Objective: 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): The incidence of adverse events AEs including the incidence of anti-AMG 531antibody formation
- Secondary Outcome Measures
Name Time Method