At a glance
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A Randomized, Double-blind, Placebo-controlled, Active Comparator Phase 2/3 Study of Tucatinib in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Subjects With Previously Treated, Locally-advanced Unresectable or Metastatic HER2+ Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
In Brief
A Phase 3 clinical trial evaluating tucatinib, trastuzumab, and 4 other interventions for Gastric Adenocarcinoma and 2 related conditions. Completed, enrolled 17 participants across 48 sites in 6 countries.
Detailed Summary
This study is being done to see if tucatinib with trastuzumab, ramucirumab and paclitaxel works better than ramucirumab and paclitaxel to treat HER2-positive (HER2+) cancer of the gut (stomach or gastroesophageal cancer). This study will also look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. Study treatment will be given in 28-day cycles. In the Phase 2 part of the trial, participants and their doctors will know what drugs are being given (open-label). In the Phase 3 part, the study is "blinded." This means that participants, their doctor, and the study sponsor will not know which drugs are being given.
Study Details
Timeline
Interventions
300 mg given twice daily orally
6 mg/kg loading dose will be administered intravenously (IV; into the vein) on Cycle 1 Day 1, followed by 4 mg/kg IV on Cycle 1 Day 15 and then Days 1 and 15 of each cycle thereafter
8 mg/kg will be administered IV on Days 1 and 15 of each cycle
60 or 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle
Given twice daily orally
IV on Days 1 and 15 of each cycle