Study of Ramucirumab, Trastuzumab and Paclitaxel in Patients With HER2-positive Recurrent/Metastatic Gastric Cancer (HER-RAM Study)

Phase 1/2 Unknown 50 enrolled Yonsei University

NaSequentialOpen-labelTreatment

Summary

Human epidermal growth factor receptor 2 (HER2) is overexpressed or amplified in 10-20% of gastric or gastroesophageal junction cancer. Trastuzumab combined with fluorouracil and platinum has been established as first-line treatment for patients with HER2-positive gastric cancer. The role of trastuzumab in second-line treatment for HER2-positive gastric cancer has not yet been addressed. Here, we evaluated the safety and efficacy of adding trastuzumab to ramucirumab and paclitaxel combination as a second-line treatment in HER2-positive gastric cancer progressed after trastuzumab-containing chemotherapy.

Timeline

Start: 2018-02-13
Primary completion: 2021-09-02
Completion: 2021-09-02

Publications

Kim CG, Jung M, Kim HS, Lee CK, Jeung HC, Koo DH, Bae WK, Zang DY, Kim BJ, Kim H, Yun UJ, Che J, Park S, Kim TS, Kwon WS, Park J, Cho SW, Nam CM, Chung HC, Rha SY. Trastuzumab Combined With Ramucirumab and Paclitaxel in Patients With Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Advanced Gastric or Gastroesophageal Junction Cancer. J Clin Oncol. 2023 Sep 20;41(27):4394-4405. doi: 10.1200/JCO.22.02122. Epub 2023 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	70 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Subject	Ramucirumab	Monoclonal antibody	8 mg/kg	Intravenous
Subject	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous

Indications

No indication recorded.