Ramucirumab Plus TAS-102 in Patients With Advanced or Metastatic Gastric Adenocarcinoma or the Gastroesophageal Junction

Summary

Participation Requirements

Description

This is an interventional, prospective, non-randomized, open-label, multicenter single-arm pilot study of ramucirumab plus TAS-102 in patients with advanced or metastatic adenocarcinoma of the stomach or the gastroesophageal junction, after treatment failure on a ramucirumab based therapy. A total n...

This is an interventional, prospective, non-randomized, open-label, multicenter single-arm pilot study of ramucirumab plus TAS-102 in patients with advanced or metastatic adenocarcinoma of the stomach or the gastroesophageal junction, after treatment failure on a ramucirumab based therapy. A total number of 20 patients will be enrolled. Potential study participants will be assessed for eligibility during one or several screening visits. The patient has to provide a signed informed consent form prior to any study-specific screening evaluations. Once the patient provides a signed informed consent form and eligibility is confirmed (all inclusion/exclusion criteria have been verified), the patient can be enrolled. All screening procedures must be completed during the 14-day screening period. All patients must have had disease status confirmed as per CT or MRI scan of the tumor(s) within ? 4 weeks prior to the first dose. Other screening assessments include blood sampling, performance status (ECOG) and ECG according to clinical routine. Study treatment will be continued until progression or intolerable toxicity, but for a maximum of 4 months. Further treatment after progression will be at the investigator's discretion. Tumor assessment will be performed according to clinical routine at screening and every 8 weeks (±7 days) during the treatment phase of the study and every 12 weeks (±14 days) during follow-up. The expected duration of the active study phase (FPI - LPO) is 18 months. The active phase per individual patient is approximately 6 months.

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