Status:
COMPLETED
Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer
Lead Sponsor:
Seagen Inc.
Conditions:
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 gast...
Eligibility Criteria
Inclusion
- 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:
- HER2 amplification in a blood-based NGS assay performed at a central laboratory, or
- HER2 overexpression/amplification immunohistochemistry (IHC) and in situ hybridization (ISH) (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
- Phase 2 dose expansion stage:
- Cohort 2A: HER2 amplification in a blood-based NGS assay performed at a central laboratory
- Cohort 2B: No HER2 amplification by blood-based NGS assay, but HER2 overexpression/amplification by IHC and ISH (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
- 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
- Subjects with squamous cell or undifferentiated GEC
- Having received more than 1 line of prior systemic therapy for locally-advanced unresectable or metastatic disease
- Having received taxanes ≤12 months prior to enrollment, prior treatment with ramucirumab, or prior treatment with tucatinib, lapatinib, neratinib, afatinib, or any other investigational anti-HER2 and/or anti-EGFR tyrosine kinase inhibitor, or with T-DM1, T-Dxd, or any other HER2-directed antibody-drug conjugate
- Phase 2 paclitaxel dose optimization stage only: history of prior partial or total gastrectomy
- Unable to swallow pills
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04499924
Start Date
March 22 2021
End Date
April 17 2024
Last Update
January 22 2025
Active Locations (48)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
3
Arizona Cancer Center / University of Arizona
Tucson, Arizona, United States, 85724
4
City of Hope National Medical Center
Duarte, California, United States, 91010