NCT00568646已完成2 期
A Phase 2 Study of Oral MKC 1, Administered Twice Daily for 14 Consecutive Days in a 28-Day Cycle, in Patients With Unresectable or Metastatic Pancreatic Cancer Who Have Failed at Least One Prior Chemotherapy Regimen in Either the Neoadjuvant, Adjuvant, or First-line Metastatic Setting
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
- 33
- 试验地点
- 2
- 主要终点
- Objective tumor response rate based on tumor measurements according to the RECIST
研究概览
简要总结
To determine the antitumor activity of MKC-1 in patients with unresectable or metastatic pancreatic cancer who have failed at least one prior chemotherapy regimen in either the neoadjuvant, adjuvant, or first-line metastatic setting
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent and Health Insurance Portability and Accountability Act authorization for release of protected health information before any study related assessments
- •Have histologically confirmed pancreatic cancer and measurable disease according to RECIST
- •Have failed at least one prior chemotherapy regimen in either the neoadjuvant, adjuvant, or first-line metastatic setting
- •Be at least 18 years of age at the time of consent
- •Have an Eastern Cooperative Oncology Group performance status of 0 or 1
- •Have the following laboratory results, within 10 days before the first MKC 1 administration:
- •Hemoglobin greater than or equal to 9 g/dL
- •Absolute neutrophil count greater than or equal to 1.5 x 109 cells/L
- •Platelet count greater than or equal to 75 x 109 cells/L
- •Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN)
- •Aspartate transaminase less than or equal to 2.5 times the ULN
- •Serum albumin greater than or equal to 3.0 g/dL
- •Total bilirubin less than or equal to the ULN
排除标准
- •Be a pregnant or breast-feeding woman. Female patients must be postmenopausal, surgically sterile, or they must agree to use a barrier method of contraception. Female patients of childbearing potential must have a negative pregnancy test within the 10 days before the first MKC 1 administration. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
- •Have known central nervous system metastases unless they are being treated, are clinically stable, and do not require the use of steroids.
- •Have clinical evidence of significant bowel obstruction, active uncontrolled malabsorption syndromes, or a history of total gastrectomy.
- •Have uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dL).
- •Have a serious cardiac condition (Class III/IV congestive heart failure according to New York Heart Association classification) or documented acute myocardial infarction within the previous 6 months.
- •Have any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. These conditions include: infection requiring parenteral or oral anti-infective treatment or any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.
- •Have had 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.
- •Be receiving treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir, and saquinavir, or any other medications that interfere with CYP3A4).
- •Have, in the opinion of the investigator, any clinically significant existing toxicities from previous chemotherapy therapies.
研究组 & 干预措施
1
Experimental
干预措施: MKC-1 (Drug)
结局指标
主要结局
Objective tumor response rate based on tumor measurements according to the RECIST
时间窗: every 8 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1Breast CancerNCT00306631CASI Pharmaceuticals, Inc.65
已完成
1 期
Safety Study of MKC-1 Combined With Pemetrexed to Treat Advanced Cancer and Non-Small Cell Lung CancerAdvanced CancerNon-Small Cell Lung CancerNCT00408226CASI Pharmaceuticals, Inc.27
终止
2 期
A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in TaiwanResected Pancreatic CancerAdjuvant ChemotherapyPancreatic CancerNCT04070313TTY Biopharm36
已完成
2 期
A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial CancerEndometrial CancerOvarian CancerNCT00607607CASI Pharmaceuticals, Inc.44
已完成
1 期
K-001 Treatment of Advanced Pancreatic Cancer: Clinical Trial of Monotherapy's TolerabilityPancreatic CancerNCT02720666Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine12