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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
63
Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
Placebo subcutaneous injection.
Intravenous infusion
Intravenous infusion
Intravenous infusion
Research Site
Glendale, Arizona, United States
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
Number of Participants With Adverse Events
This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.
Time frame: 4 months
Duration of Grade 3 or 4 Thrombocytopenia
The duration of grade 3 or 4 thrombocytopenia (defined as platelet count \<50 x 10\^9/L) experienced during the first on study chemotherapy cycle by treatment group.
Time frame: 3 weeks
Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.
The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count \< 50 x 10\^9/L, but ≥ 25 x 10\^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count \< 25 x 10\^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.
Time frame: 3 weeks
Number of Participants With Platelet Transfusions
Number of participants who were administered platelet transfusions during first on study treatment cycle.
Time frame: 3 weeks
Platelet Count on Day 22
Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group
Time frame: Day 22
Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle
Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.
Time frame: 8 days
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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
...and 103 more locations