TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03686488|
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Gastric Cancer||Drug: TAS 102 Drug: Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma|
|Actual Study Start Date :||November 29, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2023|
Experimental: TAS 102 and Ramucirumab
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
Drug: TAS 102
TAS 102 35 mg will be administered orally twice daily every 2 weeks.
Other Name: Lonsurf
Drug: Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]
Ramucirumab 8 miligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.
- Overall Survival [ Time Frame: 6 months ]Overall survival defined as the time from starting on trial to date of death from any cause.
- Number of participants with at least one adverse event [ Time Frame: 4 weeks after end of study participation ]Frequency and severity of adverse events
- Objective Response Rate (ORR) [ Time Frame: 6 months ]Response Evaluation Criteria in Solid Tumors (RECIST) based response rate
- Progression Free Survival (PFS) [ Time Frame: 6 months ]PFS, defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686488
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Neal Shah 813-745-1393 Neal.Shah@moffitt.org|
|Principal Investigator: Dae Won Kim, MD|
|Sub-Investigator: Rutika Mehta, MD, MPH|
|Sub-Investigator: Iman Imanirad, MD|
|Principal Investigator:||Dae W Kim, MD||H. Lee Moffitt Cancer Center and Research Institute|