Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)

Completed · Phase 2 · Has a placebo group

Conditions studied: Lung Cancer, Chemotherapy-Induced Thrombocytopenia, Non-Small Cell Lung Cancer, Cancer, Lung Neoplasms, Oncology, Solid Tumors, Thrombocytopenia

In brief

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 with non-small cell lung cancer receiving gemcitabine and platinum.

Key facts

Study ID: NCT00413283
Run by: Amgen
People needed: 63
Starts: 2006-12-01
Expected to finish: 2009-02-01
Last updated by the study team: 2013-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Research Site — Glendale, Arizona, United States
Research Site — Anaheim, California, United States
Research Site — Anaheim, California, United States
Research Site — Los Angeles, California, United States
Research Site — Los Angeles, California, United States
Research Site — Rancho Mirage, California, United States
Research Site — Rancho Mirage, California, United States
Research Site — Boynton Beach, Florida, United States
Research Site — Boynton Beach, Florida, United States
Research Site — Vero Beach, Florida, United States
Research Site — Vero Beach, Florida, United States
Research Site — Athens, Georgia, United States
Research Site — Athens, Georgia, United States
Research Site — Macon, Georgia, United States
Research Site — Macon, Georgia, United States
Research Site — Peoria, Illinois, United States
Research Site — Peoria, Illinois, United States
Research Site — Sioux City, Iowa, United States
Research Site — Sioux City, Iowa, United States
Research Site — Paducah, Kentucky, United States
Research Site — Paducah, Kentucky, United States
Research Site — Shreveport, Louisiana, United States
Research Site — Shreveport, Louisiana, United States
Research Site — Baltimore, Maryland, United States
Research Site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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