Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Disease Progression

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Ramucirumab

Angiogenesis Inhibitors

Growth Inhibitors

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the compassionate use program.

International Expanded Access Program to Provide Ramucirumab for the Treatment of Metastatic Gastric Cancer

An International Single-Arm Protocol to Provide Expanded Access to Ramucirumab for the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression After Prior Fluoropyrimidine and/or Platinum-Containing Chemotherapy

Eli Lilly and Company

Ramucirumab 8 mg/kg i.v. on day 1 and day 15 of a 28-day cycle and TAS-102 35 mg/m2/dose p.o. twice daily on days 1 to 5 and days 8 to 12 of a 28-day cycle Each cycle will be repeated after 28 days (from day 1) for a maximum of 4 cycles.

TAS 102

Thorsten O Götze, Dr.

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).

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.

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

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

The primary endpoint of the study is tolerability and toxicity, defined by the rate of serious adverse events (SAEs) of any cause according to CTCAE v5.0

Rate of treatment-related AEs and SAEs according to CTCAE v5.0

Rate of grade 3 or worse adverse events for neutropenia

Rate of grade 3 or worse adverse events for anemia

Rate of grade 3 or worse adverse events for leucopenia

Rate of grade 3 or worse adverse events for thrombocytopenia

Frequency of abnormal laboratory parameters

Progression Free Survival (PFS) according to RECIST 1.1, Progression free survival (PFS) is defined as the time from enrollment to the first documented evidence of disease progression or death. If no information will be available for the evaluation of progression, patients will be censored at the timepoint of last tumor assessment.

Objective response rate is defined as proportion of patients with a best overall response of complete response (CR) or partial response (PR). Tumor response will be evaluated using RECIST 1.1 criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
International Expanded Access Program to Provide Ramucirumab for the Treatment of Metastatic Gastric Cancer	NCT02065765	Metastatic Gast... Metastatic Aden...	Ramucirumab	18 Years -	Eli Lilly and Company
Ramucirumab Plus TAS-102 in Patients With Advanced or Metastatic Gastric Adenocarcinoma or the Gastroesophageal Junction	NCT04517747	Gastric Adenoca... Metastatic Aden...	Ramucirumab TAS 102	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Spots Global Cancer Trial Database for metastatic adenocarcinoma of the gastroesophageal junction