Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France

Lilly

Status

Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Treatments: Drug: Ramucirumab; Drug: Paclitaxel

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02307812

I4T-FR-JVCS (Other Identifier)

15263

Details and patient eligibility

About

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

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participant has histologically or cytologically confirmed gastric adenocarcinoma, including gastroesophageal junction (GEJ) adenocarcinoma (Participants with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ.) after prior chemotherapy.
• Acceptable prior chemotherapy regimens for this protocol are combination chemotherapy regimens that include platinum or fluoropyrimidine components (acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin; acceptable prior fluoropyrimidine agents are 5-fluorouracil (5-FU) and capecitabine). Prior trastuzumab use in human epidermal growth factor receptor 2 positive (HER2+) participants is accepted too.
• The participant is eligible for treatment by chemotherapy and has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.

Exclusion criteria

• Participant has a known allergy to any of the treatment components.