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

  • STATUS
    Recruiting
  • End date
    Jul 6, 2023
  • participants needed
    254
  • sponsor
    Basilea Pharmaceutica
Updated on 6 October 2021

Summary

The purpose of this study is to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab in patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 genetic aberrations (GA).

Description

The study comprises three 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. Patients will be treated with single-agent derazantinib or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab. The study enrolls patients with either metastatic or recurrent locally advanced HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction inoperable at the time of screening, and radiologically confirmed disease progression after one or at least one standard treatment regimen.

Details
Condition Gastric Adenocarcinoma, stomach adenocarcinoma
Treatment derazantinib, Derazantinib-paclitaxel-ramucirumab, Derazantinib-atezolizumab, Paclitaxel-ramucirumab
Clinical Study IdentifierNCT04604132
SponsorBasilea Pharmaceutica
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically-confirmed adenocarcinoma of the gastro-esophageal junction or stomach
Male or female aged 18 years
Negative HER2 status obtained from the most recent available tissue sample
Inoperable recurrent, locally advanced adenocarcinoma or progressing stage IV adenocarcinoma of the gastro-esophageal junction or stomach, and disease progression after either standard first- or second-line treatment (Substudy 1), or after standard first-line treatment (Substudies 2 and 3)
Positive test for eligible FGFR aberrations (FGFR2 fusions / rearrangements / amplifications; FGFR1, FGFR2, or FGFR3 mutations / short variants)
For Substudies 1 and 3, measurable disease as defined by the Investigator using RECIST 1.1 criteria
ECOG PS of 0 or 1
Men and women of childbearing potential must agree to avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 150 days after the last dose of either investigational drug

Exclusion Criteria

Prior anticancer or investigational drug treatment within an interval shorter than the following, as applicable
One chemotherapy or biological (e.g., antibody) cycle interval
Five half-lives of any small molecule investigational or licensed medicinal product
Two weeks, for any investigational medicinal product with an unknown half-life
Four weeks of curative radiotherapy
Seven days of palliative radiotherapy
28 days of radiotherapy
Prior treatment with FGFR Inhibitors (all substudies), and prior treatment with taxanes within 6 months prior to randomization and/or anti-VEGF(R) therapeutic antibody or pathway-targeting agents (Substudies 2 and 3), and prior treatment with anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) therapeutic antibody or pathway-targeting agents (Substudy 3)
Concurrent evidence of clinically significant corneal or retinal disorder
History of clinically significant cardiac disorders and/or a QT interval corrected by Fridericia's formula (QTcF) > 450 ms for males or > 460 ms for females
For Substudies 1 and 3, known CNS metastases
Concurrent uncontrolled or active infection with human immunodeficiency virus (HIV; known HIV 1/2 antibodies positive); active hepatitis B virus (HBV) and hepatitis C virus (HCV) co-infection; active tuberculosis (for Substudies 2 and 3)
Child-Pugh B or C liver cirrhosis, or a history of hepatic encephalopathy, hepatorenal syndrome, or clinically-meaningful ascites related to cirrhosis (for Substudies 2 and 3)
Administration of a live, attenuated vaccine within 30 days prior to randomization (for Substudy 3)
Treatment with systemic corticosteroids (except for steroidal replacement therapy) or other systemic immunosuppressive medications within 2 weeks prior to first dose of study drug or anticipated requirement for systemic immunosuppressive medications during the study (for Substudy 3)
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