NCT00607607已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •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
- •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
排除标准
- •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).
研究组 & 干预措施
A
Experimental
Ovarian Cancer Patients
干预措施: MKC-1 (Drug)
B
Experimental
Endometrial Cancer Patients
干预措施: MKC-1 (Drug)
结局指标
主要结局
Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125
时间窗: Every 4 to 8 weeks
次要结局
- Time to progression(Time of progression)
- Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests.(As reported)
研究者
研究点 (6)
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