Trial | NCT01746771  Report issue

Title

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

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    44
[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]

To assess the pharmacokinetic profile of HM781-36B(Poziotinib) combined with Paclitaxel and Trastuzumab
To evaluate anticancer activity of HM781-36B(Poziotinib) combined with Paclitaxel and Trastuzumab in patients with HER-2 positive advanced gastric cancer
To evaluate PFS(Progression-Free Survival), TTP (Time To Tumor Progression), and DOR (Duration of Overall Response)

[Phase II]

To assess the safety, tolerability of HM781-36B(Poziotinib) combined with Paclitaxel and Trastuzumab
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)
Study Started
Nov 30
2012
Primary Completion
Aug 31
2015
Study Completion
Aug 31
2015
Last Update
Mar 03
2016
Estimate

Drug HM781-36B(Poziotinib)

QD*2weeks/3weeks

  • Other names: NOV120101, Poziotinib

Drug Paclitaxel

175mg/m2

Drug Trastuzumab

8mg/kg

  • Other names: Herceptin

HM781-36B, Paclitaxel, Trastuzumab Experimental

HM781-36B(Poziotinib): QD*2weeks/3weeks Paclitaxel: 175mg/m2 Trastuzumab(Herceptin): 8mg/kg

Criteria 

Inclusion Criteria:

Histologically or cytologically confirmed advanced gastric cancer including gastroesophageal junction adenocarcinoma
At least one measurable lesion defined by RECIST(v1.1)
FISH+ or IHC3+ (regardless of FISH results)
Age≥19
ECOG ≤ 2
Life expectancy ≥ 12 weeks
Adequate bone marrow and no abnormal heart and lung function
No radiotherapy, other anticancer drugs or immunotherapy is allowed during this study
Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Exclusion Criteria:

Patients with a history of hypersensitivity to Trastuzumab and who have been treated with medicine including Cremophor EL
Patients who have a current active malignancy other than gastric adenocarcinoma (with exception of non-melanoma skin cancer or cervical cancer in situ)
Patients who have previously received taxane-based chemotherapy
The presence of central nervous system metastases
Patients who have a blood tumor such as leukemia, or who had previously received, or are planning to receive, the bone marrow transplant
Patients with uncontrolled infection
Patients who have GI malabsorption or difficulty taking oral medication
Patients with following diseases are excluded:
Patients with psychiatric or congenital disorder which can affect adherence or make hard to follow the requirements of the protocol
Pregnant or breastfeeding women or women of childbearing who do not use an appropriate method of contraception (male patient should also use an appropriate method of contraception)
No Results Posted