HER-2 Positive Advanced Gastric Cancer Clinical Trial
Official title:
A Phase I-II Study to Assess the Safety, Efficacy and Pharmacokinetic Profile of HM781-36B Combined With Paclitaxel and Trastuzumab in Patients With HER-2 Positive Advanced Gastric Cancer
[Phase I] The main objective of this study is to evaluate the safety, tolerability and
determine the Recommended Dose (RD) of HM781-36B(Poziotinib)combined with Paclitaxel and
Trastuzumab
[Phase II] The main objective of this study is to evaluate anticancer activity through
determination of response rate of HM781-36B(Poziotinib)combined with Paclitaxel and
Trastuzumab in patients with HER-2 positive advanced gastric cancer
Besides the main objectives, there are other objectives as follows:
[Phase I]
1. To assess the pharmacokinetic profile of HM781-36B(Poziotinib) combined with Paclitaxel
and Trastuzumab
2. To evaluate anticancer activity of HM781-36B(Poziotinib) combined with Paclitaxel and
Trastuzumab in patients with HER-2 positive advanced gastric cancer
3. To evaluate PFS(Progression-Free Survival), TTP (Time To Tumor Progression), and DOR
(Duration of Overall Response)
[Phase II]
1. To assess the safety, tolerability of HM781-36B(Poziotinib) combined with Paclitaxel
and Trastuzumab
2. To evaluate tumor response through determination of disease control rate ,
PFS(Progression-Free Survival), TTP (Time To Tumor Progression), and DOR (Duration of
Overall Response)
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment