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
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)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety evaluation(phase I)
Dose limiting toxicity (DLT), Maximum tolerance dose (MTD)
DLT will be evaluated on Day 21 during cycle 1
Yes
Korea: Food and Drug Administration
HM-PHI-A201
NCT01746771
November 2012
February 2015
Name | Location |
---|