A Phase IB/II Study of Derazantinib in People with Gastric or Gastroesophageal Cancer

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Full Title

A Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy with Paclitaxel, Ramucirumab or Atezolizumab in Patients with HER2-Negative Gastric Adenocarcinoma Harboring FGFR Genetic Aberrations (FIDES-03)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug derazantinib alone and with other anticancer drugs in people with inoperable or metastatic cancer of the stomach (gastric adenocarcinoma) or the junction between the esophagus and stomach (gastroesophageal junction or GEJ adenocarcinoma). Derazantinib targets cancers containing changes in the FGFR gene. It is taken orally (by mouth).

In part 1 of the study, people with FGFR-altered stomach and GEJ cancers that do not make a large amount of the HER2 protein will receive derazantinib alone. In part 2 of the study, people with FGFR-altered stomach and GEJ cancers will receive derazantinib in combination with paclitaxel chemotherapy and ramucirumab immunotherapy. Combining derazantinib with paclitaxel and ramucirumab, which are given intravenously (by vein), may make the treatment more effective.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Participants must have inoperable or metastatic stomach or GEJ adenocarcinoma that contains an alteration in the FGFR gene, such as a permanently changed gene (genetic mutation), extra copies of the gene (amplification), or a joining of the FGFR gene with part of another gene (gene fusion), and is negative for HER2.
  • The serious side effects of prior therapies should resolve before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, they must be well enough that they would be able to carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Steven Maron at 646-888-6780.

Protocol

21-245

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators