TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junct… (NCT03686488) | Clinical Trial Compass
CompletedPhase 2
TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
United States23 participantsStarted 2018-12-20
Plain-language summary
The purpose of this study is to find out if the combination of TAS 102 and Ramucirumab is safe and effective in patients with advanced, refractory gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed diagnosis of gastric and GEJ adenocarcinoma.
* Measurable or non-measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Stage IV or recurrent disease is required. An irradiated lesion is considered evaluable only if it has shown enlargement since the completion of last radiation.
* Participants must have received and progressed with prior therapy. Prior therapy with ramucirumab is not allowed. Participants must have recovered from the toxic effects of the previous anti-cancer chemotherapy (with the exception of alopecia).
* Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1
* Estimated life expectancy \> 3 months
* Adequate bone marrow, liver and renal function as assessed by the following: Hemoglobin \> 8.0 g/dl, Absolute neutrophil count (ANC) \> 1,000/mm3 independent of growth factor support, Platelet count \> 100,000/mm3, Total bilirubin \< 1.5 times upper limits of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, aspartate transaminase (AST), alanine transaminase (ALT) and Alkaline Phosphatase ≤2.5 times the ULN ( ≤5 x ULN for patients with liver involvement), Creatinine clearance ≥ 30 ml/min.
* Participants must not have had chemotherapy,major surgery, monoclonal antibody therapy or experimental therapy within the 28 days prior to the start of TAS 102 administration.
* Women of childbearing potential must have a negative serum pregnancy test…
What they're measuring
1
Overall Survival
Timeframe: 6 months
Trial details
NCT IDNCT03686488
SponsorH. Lee Moffitt Cancer Center and Research Institute