A 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

• Conditions: Secondary prophylaxis for the treatment of chemotherapy induced thrombocytopenia (CIT) in subjects with Non-Small Cell Lung Cancer (NSCLC) receiving myelosuppressive chemotherapy.; MedDRA version: 8.1Level: LLTClassification code 10023780Term: Large cell lung cancer stage IV

• Registration Number: EUCTR2006-003699-36-PT
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 95

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 < 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/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 < 3.0 x ULN (except for subjects with liver mets which will be excluded if > 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 < 1.5 x ULN

Ethical
• Before any study-specific procedure, the appropriate written informed consent must be 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified