Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France
Primary Purpose
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Ramucirumab
Paclitaxel
Sponsored by
About this trial
This is an expanded access trial for Gastric Cancer
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02307812
First Posted
November 25, 2014
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT02307812
Brief Title
Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France
Official Title
Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 15, 2023
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the ATU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ramucirumab
Other Intervention Name(s)
IMC-1121B, LY3009806
Intervention Description
Administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Administered IV
10. Eligibility
Sex
All
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France
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