NCT01839773已完成3 期
A Randomized, Open-label, Multicenter, Phase 3 Study for Efficacy and Safety Assessment of DHP107 (Oral Paclitaxel) vs. Taxol® in Patients With Metastatic or Recurrent Gastric Cancer After Failure of First-line Chemotherapy With Fluoropyrimidine +/- Platinum
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 13
- 主要终点
- Progression Free Survival
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of DHP107 (Oral paclitaxel) in comparison to Taxol®(IV paclitaxel) in Patients With Metastatic or Recurrent Gastric Cancer After Failure of 1st Line Chemotherapy With Fluoropyrimidine +/- Platinum.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥20 years of age
- •Histologically or cytologically confirmed unresectable, recurrent or metastatic gastric cancer
- •Failure of a first line therapy with fluoropyrimidine +/- platinum for metastatic or recurrent disease.(Adjuvant chemotherapy is not considered as a first line chemotherapy unless recurrence developed within 6 months of completion of adjuvant therapy.)
- •Adequate bone marrow, liver and renal functions
- •ECOG performance status ≤ 2
- •Neuropathy grade ≤ 1
- •Life expectancy of at least 3 months
- •Measurable lesion according to RECIST version 1.1 on CT scan
- •Written informed consent
- •Patients of child bearing age have to agree to the usage of adequate contraception from before the registration to the study, during the participation period and 90 days after the end of treatment. Female of child bearing age has to show negative for urin pregnancy test within 7 days from beginning of the start of administration. Amenorrhea status has to be sustained for at least 12 months to be considered non-pregnant in case of postmenstrual women.
排除标准
- •Major infectious disease, neurological disorder, or bowel obstruction.
- •Patients with CNS metastases(confirmed through brain imaging if there are symptoms)
- •Patient diagnosed with another cancer type (except non-melanoma skin cancer, cervical cancer, or any other cancer that did not recur or metastasized for more than 5 years and considered as complete remission can be registered)
- •Patient who received radiation therapy within past 2 weeks or who had major surgery including organ resection within past 4 weeks from random assignment date
- •Patient with the history of failure to the taxane chemotherapy
- •Patient who need chronic concomitant use of P glycoprotein, immune suppressor, proton pump inhibitor, or H2-receptor antagonist during the period of clinical trial
- •Chronic treatment using steroid (except oral, local injection, or for externally applied) or other immune suppressor
- •Patient with myocardial infarction, congestive heart failure, arrhythmia showing abrupt change in the ECG, severe or unstable angina, or other serious heart disease
- •Patient with other serious internal disease (chronic obstructive or chronic inhibitory lung disease including shortness of breathe at rest due to all reasons, uncontrollable diabetes and hypertension)
- •History of abuse of a drug or alcohol within 3 months
- •Lactating or pregnant women, or patient (or spouse) who has no intension of using, or cannot use very effective mean of contraception
- •Patient who has or is suspected to have problem in bile acid secretion
- •Patient with active gastrointestinal bleeding, or taking oral anti- vitamine K (With the exception of low dose of Warfarin and acetylsalicylic acide when INR≤2.0)
- •History of serious hypersensitive reaction to the main ingredient or the excipient of the investigational drug
- •History of being seropositive for HIV (HIV test is not a prerequisite).
- •Patients with gastrointestinal dysfunction or on enteral feeding
- •Other patients who are deemed inadequate to participate in the clinical trial by the investigator
研究组 & 干预措施
DHP107 (oral paclitaxel)
Experimental
DHP107 (oral paclitaxel) will be administered weekly as second line chemotherapy in patients with metastatic or recurrent gastric cancer after failure of first line chemotherapy with fluoropyrimidine +/- platinum.
干预措施: Paclitaxel (Drug)
Taxol® (IV paclitaxel)
Active Comparator
Taxol® (IV paclitaxel) will be administered 3-weekly as second line chemotherapy in patients with metastatic or recurrent gastric cancer after failure of first line chemotherapy with fluoropyrimidine +/- platinum.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Participants will be followed until progression, an expected average of 4 months.
PFS is defined as the time From date of randomization until the date of first documented progression or death, assessed up to 24 months.
次要结局
- Overall Survival(Until 6 months after the last participant is enrolled, assessed up to 24 months.)
- Overall Response Rate(Participants will be followed every 6 weeks until progression, an expected average of 4 months.)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
2 期
Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast CancerRecurrent or Metastatic Breast CancerNCT03326102Daehwa Pharmaceutical Co., Ltd.72
撤回
2 期
Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast CancerBreast CancerNCT00678626Pfizer
已完成
1 期
Pharmacokinetics of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy VolunteersHealthy VolunteersNCT06339788Handok Inc.40
已完成
2 期
Oral DS107 in Moderate to Severe Atopic DermatitisAtopic DermatitisNCT02211417Dignity Sciences Ltd.102
已完成
3 期
Paclitaxel Compared With Doxorubicin in Treating Patients With Advanced AIDS-Related Kaposi's SarcomaAIDS-related Kaposi SarcomaNCT00003350National Cancer Institute (NCI)240