EUCTR2004-002395-41-DE进行中（未招募）不适用
Phase II study of MS-275, a histone deacetylase inhibitor, comparing 2 dosage schedules in patients with metastatic melanoma - MS-275 proof of concept in melanoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Histologically confirmed nonresectable metastatic melanoma Stage III or IV (per American Joint Committee on Cancer/2002 criteria),
- •2) At least one and no more than two previous systemic therapies for metastatic melanoma (excluding prior systemic therapy given for lymph node metastasis as preoperative neoadjuvant and/or postoperative adjuvant therapy),
- •3) Presence of at least one lesion fulfilling the minimum RECIST size requirements for a target lesion (>=20 mm with conventional techniques or >=10 mm with spiral CT scan),
- •4) Able to undergo either contrast-enhanced CT scan or contrast-enhanced MRI scan for tumor assessment.
- •5) Lack of response to or progression after most recent systemic therapy for metastatic melanoma,
- •6) Life expectancy greater than 3 months,
- •7) Age >= 18 years,
- •8) Adequate organ and bone marrow functions as defined below:
- •-- Absolute neutrophil count (ANC) >=1500/µl,
- •-- Platelets >=100,000/µl,
- •-- Creatinine <=1.5 x ULN or measured creatinine clearance of >=60 ml/min x 1.73 m2 BSA,
- •-- Total bilirubin <=1.5 times upper limit of normal,
- •-- AST (SGOT) 2/2ALT (SGPT) <=2.5 times upper limit of normal,
- •9) All AEs from prior anticancer therapy have resolved to ?2Grade 1,
- •10) Able to swallow and retain intact investigational drug tablets,
- •11) Willingness and ability to return to the treatment center for follow-up as outlined in the protocol,
- •12) Have a negative serum pregnancy test within 2 weeks prior to receiving the first dose of study drug in female patients of childbearing potential. Agreement to use adequate method of contraception throughout the study period for sexually active males and females of childbearing potential,
- •13) Able to provide informed consent,
- •14) Able to complete all protocol requirements,
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Pregnancy, breast feeding,
- •2) Diagnosis of uveal melanoma,
- •3) Known history of HIV infection,
- •4) ECOG performance status >= 2,
- •5) Active malignancy in the 5 years prior to enrollment other than non-uveal melanoma, basal cell carcinoma, or cervical carcinoma in situ,
- •6) Ongoing effects from previous investigational drug studies or concomitant participation in other investigational drug studies
- •7) Prior use of MS-275 or any other HDAC inhibitor,
- •8) History of allergic reactions attributed to compounds of similar chemical or biologic composition to MS-275,
- •9) Known or suspected brain metastases,
- •10) Anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy, and hormone therapy) delivered within 4 weeks prior to the 1st dose of study drug, and 2 weeks prior for palliative spot” radiotherapy to bone metastases),
- •11) Active gastrointestinal conditions (e.g., gastric resection, colitis, or prior intestinal surgery) that might predispose for poor drug absorption,
- •12) Major surgery (including but not limited to thoracic, abdominal, pelvic, or ophthalmologic surgery, neurosurgery, and large joint surgery such as knee or hip procedures) within 4 weeks prior to enrollment,
- •13) Concomitant use of corticosteroids (except when administered for refractory nausea/vomiting) or valproic acid,
- •14) Uncontrolled intercurrent illness—including but not limited to—ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements,
- •15) Hypophosphatemia < 2.5 mg/dl (0.8 mmol/l) at screening, if not corrected in the screening period
- •16) Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
- •17) Prior enrollment into this study.
研究者
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