Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer

Brief summary public domain (ClinicalTrials.gov)

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer

Detailed description public domain (ClinicalTrials.gov)

RECITE: 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

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percentage of Participants Who Had Thrombocytopenia-induced Dose Modification [Day 1 up to Week 12]. Number, percentage of participants (95% Confidence Interval). Romiplostim (n=109): 84.4 (76.21 to 90.64); Placebo (n=56): 35.7 (23.36 to 49.64). Analysis, Romiplostim vs Placebo: Odds Ratio (OR) 10.16 (95% CI 4.44 to 23.72); p=< 0.001; Cochran-Mantel-Haenszel; superiority.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Platelet Count Nadir at the End of the Treatment Period [Up to 21 weeks]. Least Squares Mean, 10^9 platelets per L (95% Confidence Interval). Romiplostim (n=109): 77.3 (66.5 to 88.0); Placebo (n=56): 51.1 (36.4 to 65.8). Analysis, Romiplostim vs Placebo: Mean difference 26.1 (95% CI 7.9 to 44.4); p=0.005; General linear model; superiority.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Kaplan-Meier Estimate of Time to First Platelet Response [Up to 21 weeks]. Median, weeks (95% Confidence Interval). Romiplostim (n=109): 1.1 (NA to NA) [The upper and lower 95% CIs of the median were not estimable as no participants were censored or had any events for the interval from the first quarter to the median month (i.e., no variability).]; Placebo (n=56): 2.1 (1.1 to 3.0). Analysis, Romiplostim vs Placebo: Hazard Ratio (HR) 2.673 (95% CI 1.808 to 3.952); p=< 0.001; Cox proportional hazards; superiority.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration-adjusted Event Rate of Bleeding Events in the Treatment Period [Up to 21 weeks]. Number, bleeding events per 100 subject-years. Romiplostim (n=109): 4.0; Placebo (n=56): 7.6. Analysis, Romiplostim vs Placebo: Hazard Ratio (HR) 0.53 (95% CI 0.04 to 6.77); p=0.63; Andersen-Gill model; superiority.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [From Day 1 up to 1 year after last dose of investigational product (IP) (max 1869 days)]. Median, months (95% Confidence Interval). Romiplostim (n=109): 21.0 (15.4 to 45.3); Placebo (n=56): 46.0 (22.2 to NA) [As more than half of the participants were censored, not enough deaths occurred to estimate CI Upper Limit.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants Who Had Platelet Transfusions During the Treatment Period [Up to 21 weeks]. Number, percentage of participants (95% Confidence Interval). Romiplostim (n=109): 1.8 (0.22 to 6.47); Placebo (n=56): 0.0 (0.00 to 6.38).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants Who Achieved a Platelet Count ≥ 100 x 10^9/L [Day 1 to Week 4]. Number, percentage of participants (95% Confidence Interval). Romiplostim (n=109): 96.3 (90.87 to 98.99); Placebo (n=56): 66.1 (52.19 to 78.19). Analysis, Romiplostim vs Placebo: Odds Ratio (OR) 16.19 (95% CI 4.38 to 88.85); superiority.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Fatal AEs [From first dose of IP to 30 days after last dose of IP: median (min, max) duration was 86.0 (31.0, 184.0) days]. Count Of Participants, Participants. TEAEs: Romiplostim (n=110): 96; Placebo (n=55): 34. SAEs: Romiplostim (n=110): 23; Placebo (n=55): 3. Fatal AEs: Romiplostim (n=110): 2; Placebo (n=55): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants Who Developed Anti-romiplostim Antibodies and Anti-thrombopoietin (TPO) Antibodies [Up to 21 weeks]. Count Of Participants, Participants. Romiplostim: Binding antibodypositive at or before baseline: Romiplostim (n=110): 2; Placebo (n=55): 0. Romiplostim: Neutralizingantibody positive at or beforebaseline: Romiplostim (n=110): 0; Placebo (n=55): 0. Romiplostim: Binding antibodypositive post-baseline with anegative or no result at baseline: Romiplostim (n=110): 1; Placebo (n=55): 0. Romiplostim: Neutralizingantibody positive post-baselinewith a negative or no result atbaseline: Romiplostim (n=110): 0; Placebo (n=55): 0. TPO: Binding antibody positiveat or before baseline: Romiplostim (n=110): 0; Placebo (n=55): 0. TPO: Neutralizing antibodypositive at or before baseline: Romiplostim (n=110): 0; Placebo (n=55): 0. TPO: Binding antibody positivepost-baseline with a negative orno result at baseline: Romiplostim (n=110): 1; Placebo (n=55): 0. TPO: Neutralizing antibodypositive post-baseline with anegative or no result at baseline: Romiplostim (n=110): 0; Placebo (n=55): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants Who Reported Myelodysplastic Syndromes (MDS) and SecondaryMalignancies [From Day 1 up to 1 year after last dose of IP (max 1869 days)]. Count Of Participants, Participants. MDS: Romiplostim (n=110): 1; Placebo (n=55): 0. Secondary Malignancy: Romiplostim (n=110): 2; Placebo (n=55): 3.