A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer (RECITE)

Conditions

Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer

Brief summary

No thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L

Detailed description

The depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period, The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days, The duration-adjusted event rate of ≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale, Overall Survival, Platelet transfusion(s) during the treatment period, achieving a platelet count ≥ 100 x 109/L at any time after study day 1 to week 4 (ie, 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days, Adverse events, including treatment-emergent adverse events, fatal adverse events, serious adverse events, and clinically significant changes in laboratory values. Anti-romiplostim antibodies and antibodies to thrombopoietin (TPO) myelodysplastic syndromes and secondary malignancies

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Interventions

DRUGNplate 500 micrograms powder and solvent for solution for injection

DRUGPlacebo will be provided in identical 5 mL single-use vials as a sterile

DRUGwhite

DRUGpreservative-free

DRUGlyophilized powder containing histidine

DRUGmannitol

DRUGsucrose

DRUGand polysorbate 20 and has a pH 5.0 when reconstituted with sterile water for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
No thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L	—

Secondary

Measure	Time frame
The depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period, The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days, The duration-adjusted event rate of ≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale, Overall Survival, Platelet transfusion(s) during the treatment period, achieving a platelet count ≥ 100 x 109/L at any time after study day 1 to week 4 (ie, 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days, Adverse events, including treatment-emergent adverse events, fatal adverse events, serious adverse events, and clinically significant changes in laboratory values. Anti-romiplostim antibodies and antibodies to thrombopoietin (TPO) myelodysplastic syndromes and sec	—

Measure

Time frame

The depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period, The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days, The duration-adjusted event rate of ≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale, Overall Survival, Platelet transfusion(s) during the treatment period, achieving a platelet count ≥ 100 x 109/L at any time after study day 1 to week 4 (ie, 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days, Adverse events, including treatment-emergent adverse events, fatal adverse events, serious adverse events, and clinically significant changes in laboratory values. Anti-romiplostim antibodies and antibodies to thrombopoietin (TPO) myelodysplastic syndromes and sec

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Countries

Bulgaria, France, Greece, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed