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临床试验/NCT01276548
NCT01276548已完成2 期

A Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer

Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate

研究概览

简要总结

The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Subjects who aged 18 years or older
  • Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
  • Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.

排除标准

  • Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication.
  • Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial.
  • Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit

研究组 & 干预措施

Genexol®-PM plus Carboplatin

Experimental

干预措施: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC (Drug)

Genexol® plus Carboplatin

Active Comparator

干预措施: Genexol® 175mg/m2 plus Carboplatin 5 AUC (Drug)

结局指标

主要结局

To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate

时间窗: up to 6 cycles

Proportion of subjects with CA125 and RECIST composite response rate was evaluated and compared between the groups. CA125 was evaluated among subjects without a measurable disease, while RECIST was evaluated among subjects with a measurable disease; discordance between the response rates by RECIST and CA125 were deemed as nonresponse.

次要结局

  • Overall Survival(up to 3 years)
  • Progression Free Survival(up to 3 years)
  • Time to Progression(up to 3 years)

研究者

发起方
Samyang Biopharmaceuticals Corporation
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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