Trial intelligence / Profile preview

IV Ferric Carboxymaltose for Iron-Deficiency Anemia in Advanced Gastric Cancer

NCT05226169Phase 3

Key facts

Status: Recruiting
Start: Apr 2022
Primary completion: Nov 2026
Countries: 1
Sponsor: Asan Medical Center
Modality: Small Molecules

Drugs: ferric carboxymaltose
Conditions: iron deficiency anemia (IDA)

Overview

Phase 3, randomised, open-label trial of ferric carboxymaltose in iron deficiency anemia (IDA) (2 arms), sponsored by Asan Medical Center. Primary endpoint: Maximum change of Hemoglobin concentration at 12 weeks. Started Apr 2022; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Active treatment arm : IV FCM
Intravenous ferric carboxymaltose 1000 mg on day 1, then 500 mg at weeks 6, 12, 24, 36, 48 if indicated
Control treatment arm: Conservative management
Oral ferrous sulfate or no treatment according to physician's choice

Who it enrols

Adult patients with locally advanced or metastatic gastric/GEJ adenocarcinoma scheduled for first-line palliative fluoropyrimidine/platinum chemotherapy, who have iron-deficiency anemia (Hb 8-<11 g/dL) and adequate organ function.

Endpoints

Primary

Maximum change of Hemoglobin concentration12 weeks

Secondary

Change of Hemoglobin concentration48 weeks
Change in serum iron48 weeks
Change in serum ferritin48 weeks
Change in serum total iron-binding capacity48 weeks
Change in serum transferrin saturation48 weeks
Tumor response24 months
Progression-Free Survival24 months
Overall Survival2 years

Beyond the preview

Go deeper on NCT05226169.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05226169.