Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma

Active:	No
Cancer Type:	Stomach/ Gastric Cancer Unknown Primary	NCT ID:	NCT04604132
Trial Phases:	Phase I Phase II	Protocol IDs:	DZB-CS-202 (primary) NCI-2021-01098
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Basilea Pharmaceutica
NCI Full Details:	http://clinicaltrials.gov/show/NCT04604132

Summary

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).

Objectives

The study comprised two open-label substudies in patients with HER2-negative
adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 gene
translocations, FGFR2 gene amplifications, or FGFR1-3 mutations.

In Substudy 1, GAC patients with specified FGFR GAs, after either first- or second-line
treatment, and no approved treatment alternative were treated with derazantinib 300 mg
once daily or 200 mg twice daily, with the aim of evaluating the safety, tolerability,
and efficacy of derazantinib monotherapy in this patient population.

In Substudy 2, GAC patients with specified FGFR GAs after standard first-line treatment,
were treated with a derazantinib-paclitaxel-ramucirumab combination with the aim of
evaluating the safety, tolerability, and efficacy of the combination therapy and
determining the recommended phase 2 dose (RP2D).

The study originally planned to include three substudies but was prematurely terminated
for administrative reasons before the third substudy (including combination therapy with
derazantinib plus atezolizumab) was initiated.

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