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

What Was Tested

The trial (phase 3) is built around Romiplostim.

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

It had two arms (groups): Romiplostim (experimental) and Placebo (placebo comparator).

The registry classes the interventions as biological and other.

More on the Plan

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.

Who Took Part

Enrollment: 165 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males or females greater than or equal to 18 years of age at signing of the informed consent. Subjects must have a local platelet count ≤ 85 x 10\^9/L on study day 1. Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

The full record lists 8 inclusion and 36 exclusion criteria; among the exclusions: acute lymphoblastic leukemia; acute myeloid leukemia; any myeloid malignancy.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Romiplostim study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Romiplostim study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2019-09-30 with completion listed for 2024-01-25.

It ran at 117 sites in United States (22), Russia (13), Turkey (Türkiye) (13), Greece (7), Romania (7) and Brazil (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Platelet Count Nadir at the End of the Treatment Period, Kaplan-Meier Estimate of Time to First Platelet Response, Duration-adjusted Event Rate of Bleeding Events in the Treatment Period, Overall Survival, Percentage of Participants Who Had Platelet Transfusions During the Treatment Period and Percentage of Participants Who Achieved a Platelet Count ≥ 100 x 10^9/L.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 165 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Romiplostim compound page, all human trials.