A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer
2012年1月19日 更新者:CASI Pharmaceuticals, Inc.
A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Recurrent or Resistant Epithelial Ovarian Cancer or Advanced Endometrial Cancer
Patients will be treated with MKC-1, twice daily for 14 consecutive days every four weeks (a cycle of MKC-1 chemotherapy), until disease progression or unacceptable toxicities.
Patients will be stratified to Arm A (ovarian cancer) or Arm B (endometrial cancer), and will receive identical treatment regimens.
研究概览
研究类型
介入性
注册 (实际的)
44
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
-
Hamilton、Ontario、加拿大、L8V 5C2
- Juravinski Cancer Centre
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Kingston、Ontario、加拿大、K7L 5P9
- Cancer Centre of Southeastern Ontario At Kingston General Hospital
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London、Ontario、加拿大、N6A 4L6
- London Health Sciences Centre
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Mississauga、Ontario、加拿大、L5M 2N1
- Credit Valley Hospital
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Toronto、Ontario、加拿大、M5G 2M9
- Princess Margaret Hospital
-
-
Quebec
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Montreal、Quebec、加拿大、H2L 4M1
- Hopital Notre-Dame du CHUM
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Provide written informed consent (and HIPAA authorization for release of protected health information, as applicable) prior to any study related assessments.
- Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis, fallopian tube cancers, or endometrial cancer.
- Age > 18 years at the time of consent.
Arm A: Ovarian Cancer Patients:
- Must have failed at least one prior platinum based and one taxane based chemotherapeutic regimen. [Platinum failure is defined as platinum-refractory (progression while receiving a platinum-containing regimen) or platinum-resistant (disease progression within 6 months from completion of platinum containing regimen)].
- Have measurable disease according to RECIST or CA 125 criteria according to GCIG (CA-125 value of > 2 xULN).
- Have no more than 3 prior regimens for their disease.
Arm B: Endometrial Cancer Patients:
- Have no more than 3 prior regimens for their disease
- Have measurable disease according to RECIST.
- ECOG performance status of 0, 1, or 2.
The following laboratory results, within 10 days of MKC-1 administration:
- Hemoglobin greater than or equal to 90 g/L (9 g/dL)
- Absolute neutrophil count greater than or equal to 1.5 x 109/L
- Platelet count greater than or equal to 100 x 109/L
- Serum creatinine less than or equal to 1.5 x ULN (upper limit of normal)
- AST less than or equal to 2.5 x ULN
- Serum Albumin greater than or equal to 30 g/L (3.0 g/dL)
- Total bilirubin less than or equal to ULN
Exclusion Criteria:
Administration of cancer specific therapy within the following periods prior to study drug initiation:
- chemotherapy less than 3 weeks prior;
- hormonal therapy less than one week prior;
- radiation therapy less than 2 weeks prior.
- Requirement for paracentesis > 2 liters/week.
- Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile, or they must agree to use a physical method of contraception. Female patient with childbearing potential must have a negative pregnancy test within 10 days before the first MKC-1 administration.
- Known CNS metastases unless treated, clinically stable, and not requiring steroids.
- Clinical evidence of significant bowel obstruction, active uncontrolled malabsorption syndromes, or a history of total gastrectomy.
- Uncontrolled hypercalcemia (serum calcium-corrected > 3 mmol/L [12 mg/dL]).
- Serious cardiac condition (Class III/IV congestive heart failure according to New York Heart Association classification); documented acute myocardial infarction within the previous 6 months.
- Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. These include: infection requiring parenteral or oral anti-infective treatment, any altered mental status, or any psychiatric condition that would interfere with the understanding of the informed consent.
- Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix.
- Treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir and saquinavir).
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:A
Ovarian Cancer Patients
|
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
|
实验性的:B
Endometrial Cancer Patients
|
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125
大体时间:Every 4 to 8 weeks
|
Every 4 to 8 weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
进展时间
大体时间:进展时间
|
进展时间
|
Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests.
大体时间:As reported
|
As reported
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Amit Oza, MD、Princess Margaret Hospital, Canada
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年1月1日
初级完成 (实际的)
2011年6月1日
研究完成 (实际的)
2012年1月1日
研究注册日期
首次提交
2008年1月23日
首先提交符合 QC 标准的
2008年1月23日
首次发布 (估计)
2008年2月6日
研究记录更新
最后更新发布 (估计)
2012年1月20日
上次提交的符合 QC 标准的更新
2012年1月19日
最后验证
2012年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
MKC-1的临床试验
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)完全的
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)完全的
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)完全的