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临床试验/NCT01746771
NCT01746771已完成1 期

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

Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2012年11月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Safety evaluation(phase I)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

[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

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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)
  • •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

排除标准

  • •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)

研究组 & 干预措施

HM781-36B, Paclitaxel, Trastuzumab

Experimental

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

干预措施: HM781-36B(Poziotinib) (Drug)

HM781-36B, Paclitaxel, Trastuzumab

Experimental

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

干预措施: Paclitaxel (Drug)

HM781-36B, Paclitaxel, Trastuzumab

Experimental

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

干预措施: Trastuzumab (Drug)

结局指标

主要结局

Safety evaluation(phase I)

时间窗: DLT will be evaluated on Day 21 during cycle 1

Dose limiting toxicity (DLT), Maximum tolerance dose (MTD)

次要结局

  • Efficacy evaluation(Phase II)(Efficacy will be evaluated every 6 weeks or 9 weeks)

研究者

发起方
Hanmi Pharmaceutical Company Limited
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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