NCT00372437已完成1 期
A Phase I/II Study of MGCD0103 (MG-0103) in Combination With Gemcitabine
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 8
- 主要终点
- Maximum tolerated dose in combination with azacitidine
研究概览
简要总结
Inthis study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with gemcitabine to patients with solid tumours.
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
- •Patients must have histologically or cytologically documented cancer: Phase I--solid tumors where gemcitabine is considered standard of care; refractory solid tumor with no reasonable likelihood of achieving clinical benefit with existing therapies, that has failed to respond to standard therapy, has progressed despite standard therapy, or for which no standard therapy exists. Phase II--locally advanced and measurable (non-resectable III) or metastatic (Stage IV) pancreatic cancer.
- •Patients with known CNS metastases may be enrolled on Phase I or II only if they meet the following criteria:
- •They have received radiotherapy for their CNS disease;
- •They have had steroids discontinued for at least 1 month prior to study entry;
- •They have had a CT or MRI of the brain within 1 month of study entry that shows stable disease; and d)they are free of neurological symptoms.
- •Karnofsky performance status of 70 or greater.
- •Age 18 years and over.
- •Laboratory requirements (must be done within 14 days prior to study initiation):
- •Hematology: White Blood Cells (WBC)≥3 x 10<9>/L (≥ 3000/mm3);
- •Absolute Neutrophil Count (ANC) ≥1.5 x 10<9>/L (≥1500/mm3);
- •Platelets ≥100 x 10<9>/L (≥100,000/mm3);
- •Chemistry: Total Bilirubin ≤1.5 x Upper Limit of Normal(ULN);
- •AST(SGOT)and ALT(SGPT)≤3 x ULN; ≤ 5 x ULN if documented liver metastases;
- •Serum Creatinine ≤1.5 x ULN or calculated creatinine clearance ≥50 mL/min;
- •Urinalysis: Proteinuria <1 mg/dl or 500 mg protein/24 hours if dipstick ≥2+.
- •Patients or their legal representative must be able to read (or have read to them), understand, and sign a written informed consent (approved by the institutional review board/Ethics Committee (IRB/EC)) within 14 days prior to start of treatment.
排除标准
- •Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia (CIN/cervical in situ or melanoma in situ). (Phase II portion only)
- •Pregnant or lactating women. Women of child bearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior to starting study drug.
- •WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following study drug treatment. Patients unwilling or unable to follow this guideline will be excluded. Investigators should follow their Institutional standard regarding acceptable methods of contraception.
- •Patients with uncontrolled concomitant illness, active infection requiring i.v. antibiotics, or uncontrolled infections, or a fever >38.5C on the day of scheduled dosing.
- •Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
- •Patients who have been treated with any investigational drug within 28 days prior to study initiation (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
- •Known hypersensitivity to HDAC inhibitors or to any of the components of MG-
- •Known hypersensitivity to gemcitabine.
- •Prior treatment with gemcitabine (during the expanded phase II portion only).
- •Known HIV or known active Hepatitis B or C.
- •Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc.) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and undergo study procedures.
- •Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures. For example, consider requirement to take MG-0103 with a low pH drink and recommendation to avoid agents that increase gastric pH.
研究组 & 干预措施
1
Experimental
干预措施: Gemcitabine (Drug)
1
Experimental
干预措施: MGCD0103 (Drug)
结局指标
主要结局
Maximum tolerated dose in combination with azacitidine
时间窗: 1 year (anticipated)
Response rate
时间窗: 1 year (anticipated)
次要结局
- Objective response.(1 year (anticipated))
- Pharmacodynamics (histone acetylation, biomarkers)(1 year (anticipated))
研究者
研究点 (8)
Loading locations...
相似试验
已完成
1 期
A Phase I/II Study of MGCD0103 With Azacitidine in Patients With High-Risk Myelodysplastic Syndrome (MDS) or Acute Myelogenous LeukemiaAcute Myelogenous LeukemiaMyelodysplastic SyndromeNCT00324220Mirati Therapeutics Inc.66
已完成
2 期
A Phase II Study of MGCD0103 (MG-0103) in Patients With Refractory Chronic Lymphocytic LeukemiaLymphocytic Leukemia, ChronicNCT00431873Mirati Therapeutics Inc.21
已完成
1 期
Study of MGCD0103 Given Three-Times Weekly in Patients With Advanced Solid Tumors or Non-Hodgkin's LymphomaTumorsNon Hodgkin's LymphomaNCT00323934Mirati Therapeutics Inc.42
已完成
1 期
A Phase I Study of MGCD0103 Given Three-Times Weekly In Patients With Leukemia Or Myelodysplastic SyndromesMyelodysplastic SyndromesLeukemiaNCT00324129Mirati Therapeutics Inc.29
终止
2 期
MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory DiseaseMyelogenous Leukemia, AcuteMyelodysplastic SyndromesNCT00374296Mirati Therapeutics Inc.35