Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC)
HER2+ disease documented since progression of the most recent line of systemic therapy, as follows:
Phase 2 paclitaxel dose optimization stage:
Phase 2 dose expansion stage:
Phase 3: HER2 amplification in a blood-based NGS assay performed at a central laboratory
History of prior treatment with a HER2-directed antibody
Progressive disease during or after first-line therapy for locally-advanced unresectable or metastatic GEC
Phase 2: Measurable disease according to RECIST version 1.1
Phase 3: Measurable or non-measurable disease according to RECIST version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Life expectancy of at least 3 months, in the opinion of the investigator
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
17 participants in 4 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal