Trials / Completed
CompletedNCT04499924
Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer
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)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Seagen Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tucatinib | 300 mg given twice daily orally |
| DRUG | trastuzumab | 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 |
| DRUG | ramucirumab | 8 mg/kg will be administered IV on Days 1 and 15 of each cycle |
| DRUG | paclitaxel | 60 or 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle |
| OTHER | tucatinib placebo | Given twice daily orally |
| OTHER | trastuzumab placebo | IV on Days 1 and 15 of each cycle |
Timeline
- Start date
- 2021-03-22
- Primary completion
- 2024-04-17
- Completion
- 2024-04-17
- First posted
- 2020-08-05
- Last updated
- 2025-01-22
- Results posted
- 2025-01-22
Locations
48 sites across 6 countries: United States, Australia, Canada, South Korea, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04499924. Inclusion in this directory is not an endorsement.