Status:
COMPLETED
Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Amgen
Conditions:
Lung Cancer
Chemotherapy-Induced Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed locally advanced or metastatic stage IIIB or stage IV NSCLC receiving 21-day cycles of gemcitabine/carboplatin or gemcitabine/cisplatin
- Life expectancy ≥ 12 weeks at the time of screening
- Thrombocytopenia as evidenced by a platelet count ≤ 50 x 10\^9/L during the qualifying cycle of chemotherapy, OR platelet count \< 100 x 10\^9/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 patient 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)
- Absolute neutrophil count (ANC) ≥ 1,000/µL, hemoglobin ≥ 9.5 g/dL, and platelet count ≥ 100 x 10 \^9/L on Day 1 of the first on study chemotherapy treatment cycle
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of screening
- Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN) (except for patients with a confirmed diagnosis of Gilbert's Syndrome)
- Adequate renal function; serum creatinine \< 1.5 x ULN
Exclusion
- Receipt of \> 1 prior systemic chemotherapy regimen
- Sepsis, disseminated coagulation or any other condition (i.e. immune \[idiopathic\] thrombocytopenic purpura \[ITP\], thrombotic thrombocytopenic purpura \[TTP\], hemolytic uremic syndrome \[HUS\]) that may exacerbate thrombocytopenia
- History of unstable angina, congestive heart failure, uncontrolled hypertension (diastolic \> 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year of screening ) myocardial infarction
- 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)
- Use of any nitrosourea or mitomycin-C within 6 weeks of screening
- Have received any thrombopoietic growth factor or related substance
- Have received granulocyte macrophage colony stimulating factor (GM-CSF) within the last 4 weeks prior to screening
- Have received any experimental therapy within 4 weeks prior to screening
- Have ever received a bone marrow or peripheral blood stem cell infusion (within 1 year of screening)
- Known hypersensitivity to any recombinant E. coli-derived product.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00413283
Start Date
December 1 2006
End Date
February 1 2009
Last Update
October 24 2013
Active Locations (113)
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1
Research Site
Glendale, Arizona, United States, 85304
2
Research Site
Glendale, Arizona, United States
3
Research Site
Anaheim, California, United States, 92801
4
Research Site
Anaheim, California, United States