18 and older, any sex, with Gastric Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) in Substudy 1 (in Cohorts 1.1 and 1.2)Primary· From first dose and up to 18 months
ORR was defined by the percentage of patients with confirmed complete response (CR, which means disappearance of all target lesions) or partial response (PR, which means \>=30% decrease in the sum of the longest diameter of target lesions) by blinded independent central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST 1.1). Overall Response (OR) = CR + PR.
The patients in Cohort 1.1 had FGFR2 fusions or amplification gastric adenocarcinoma (GAC) and FGFR1-3 mutations GAC in Cohort 1.2.
Group
Value
95% CI
Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily
0.0
0.0 – 20.6
Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily
0.0
0.0 – 31.2
Progression-free Survival at 4 Months (PFS4) in Substudy 1 in Cohort 1.3Primary· From first dose and up to 4 months
PFS4 was defined by the percentage of patients alive and free of disease progression (defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) by BICR per RECIST. 1.1. Patients in this Cohort had FGFR fusions, amplifications or mutations GAC
Recommended Phase 2 Dose (RP2D) in Substudy 2 (Derazantinib-paclitaxel-ramucirumab in Combination)Primary· From first dose and up to 18 months
RP2D was determined from safety and tolerability according to the aggregate of dose-limiting toxicity criteria and adverse event (AE) data, and considering further pharmacokinetic and efficacy data of the derazantinib-paclitaxel-ramucirumab combination in patients with FGFR fusions, amplifications or mutations GAC.
DOR in Substudy 2 (Separate and Combined Cohorts)Secondary· From first dose and up to 15 months
DOR was calculated from the first date of documented tumor response to disease progression by BICR per RECIST version 1.1 (or death if no documentation of PD is obtained).
Group
Value
95% CI
Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab
9.2
NA – NA
Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab
PFS in Substudy 2Secondary· From first dose and up to 15 months
PFS was calculated from patient enrollment to progressive disease (PD) date by BICR per RECIST version 1.1.
Group
Value
95% CI
Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab
11.1
1.6 – NA
Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab
NA
1.7 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily
Serious: 7/13 (54%)
Deaths: 10/13
Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily
The purpose of this study was to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel and ramucirumab in patients with gastric adenocarcinoma (GAC) i.e. with human epidermal growth factor receptor 2 (HER2)-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring fibroblast growth factor receptor 2 (FGFR2) genetic aberrations (GA).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Basilea Pharmaceutica
Last refreshed: 4 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04604132.