Clinical trial: Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma (NCT04604132)

Eligibility criteria:
Key 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

          -  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

        Key Exclusion Criteria:

          -  Prior anticancer or investigational drug treatment within an interval shorter than the
             following, as applicable:

               1. One chemotherapy or biological (e.g., antibody) cycle interval

               2. Five half-lives of any small molecule investigational or licensed medicinal
                  product

               3. Two weeks, for any investigational medicinal product with an unknown half-life

               4. Four weeks of curative radiotherapy

               5. Seven days of palliative radiotherapy

               6. 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)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment