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

Gastric Adenocarcinoma Clinical Trial

Official title: A Pilot Study of Ramucirumab Beyond Progression 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

Status Completed

Clinical Trial Summary

The objective of this study is to determine whether a combination of ramucirumab, beyond progression after a SOC 2nd line ramucirumab based pre-treatment (Ram beyond progression) in patients with locally advanced or metastatic adenocarcinoma, plus TAS-102 shows good tolerability without safety issues regarding the serious adverse event rate of any cause, and whether the combination shows positive signals regarding efficacy in the secondary endpoints (e.g. prolongation of progression-free survival of TAS-102 plus ramucirumab compared with TAS-102 monotherapy - historical data according to TAGS trial).

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma
• Metastatic Adenocarcinoma of the Gastroesophageal Junction

• NCT number: NCT04517747
• Study type: Interventional
• Source: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Completion date: January 20, 2023