MedTrace Logo

A Phase I-II Study of HM781-36B Combined With Paclitaxel and Trastuzumab in HER-2 Positive Advanced Gastric Cancer

NCT01746771 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-03-03

No results posted yet for this study

Summary

\[Phase I\] 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

Conditions

  • HER-2 Positive Advanced Gastric Cancer

Interventions

DRUG

HM781-36B(Poziotinib)

QD\*2weeks/3weeks

DRUG

Paclitaxel

175mg/m2

DRUG

Trastuzumab

8mg/kg

Sponsors & Collaborators

  • National OncoVenture

    collaborator OTHER

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • YoHan Kim, M.D. · Hanmi Pharmaceutical Company Limited

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01746771 on ClinicalTrials.gov