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

What Was Tested

The trial (phase 2) is built around Romiplostim.

It had four arms (groups): Placebo (placebo comparator), one (experimental), one (experimental) and one (experimental).

Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

The registry classes the interventions as biological and drug.

Who Took Part

Enrollment: 63 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: 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. 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.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: 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 arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

The Romiplostim group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Romiplostim.

Those kept unaware of assignments: participant and investigator.

It started in 2006-12 with completion listed for 2008-12.

It ran at 113 sites in United States (51), Hungary (17), Austria (12), Germany (8), Italy (8) and Portugal (8).

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Adverse Events (time frame: 4 months).

It also tracked 5 secondary outcomes, for example Duration of Grade 3 or 4 Thrombocytopenia, Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle, Number of Participants With Platelet Transfusions and Platelet Count on Day 22.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Romiplostim in 63 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.