drugset
drugset / Trial / NCT04430738

Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

NCT04430738 ↗

Phase 2 Active not recruiting 40 enrolled Pfizer
Non-randomizedSequentialOpen-labelTreatment

Summary

This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will 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. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).

Timeline

Start
2020-09-15
Primary completion
2024-07-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Trastuzumab Monoclonal antibody 4 mg/kg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Subject Tucatinib Small molecule 150 mg Oral
Subject Tucatinib Small molecule 300 mg Oral
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

cholangiocarcinoma colorectal carcinoma esophageal adenocarcinoma gallbladder carcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma