EUCTR2009-011498-34-DE进行中（未招募）不适用
An Open-Label, Multi-Center Phase I/II Dose Escalation Study to Investigate the Safety and Tolerability of Multiple Doses of Oral Tasidotin HCL in Patients with Advanced Solid Tumors (part A), and combination of Oral Tasidotin HCl with Intravenous DTIC in Chemotherapy Naive Patients with Malignant Melanoma (part B).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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)Have a histologically or cytologically confirmed advanced malignant solid tumor that is not amenable to surgery or radiation therapy with curative intent or that has progressed or recurred after prior standard therapy.
- •After the MTD is determined in Part A, patients must have a diagnosis of metastatic melanoma and have lesions accessible for biopsy.
- •(2)Systemic chemotherapy naïve patients (Part B only)
- •(3)Have a measurable lesion according to RECIST by computerized tomography (CT) or other techniques, except for metastatic prostate cancer that may be based on prostate specific antigen (PSA) progression after previous treatment with hormonal therapy.
- •(4)Male or female patient at least 18 years old.
- •(5)ECOG performance status 0, 1, or 2.
- •(6)Life expectancy of at least 12 weeks.
- •(7)Patient has adequate organ and immune system function as indicated by the laboratory values in the protocol
- •(8)Any chemotherapy, major surgery, or irradiation must have been completed at least 4 weeks prior to starting treatment with study drug (6 weeks for mitomycin-C or nitrosourea). Additionally, patients must have recovered from clinically significant toxicities incurred as a result of previous therapy except nail dystrophy, alopecia, grade 1 peripheral neuropathy, or local radiation therapy induced effects (i.e., impotence or incontinence).
- •(9)Be able to comply with study procedures and follow-up examinations.
- •(10)Not pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy.
- •(11)Signed informed consent.
- •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)Received previous treatment with tasidotin HCl or known hypersensitivity to tasidotin HCl or its analogues.
- •(2) Known hypersensitivity to DTIC (Part B only).
- •(3)Received radiotherapy to the only site of measurable disease.
- •(4)Used any investigational agents during the 30 days prior to the first dose.
- •(5)Use of any immune-suppressive agents such as the regular use of systemic corticosteroids for the part 4 weeks prior to study start
- •(6)Has any clinical indication that may affect gastrointestinal (GI) absorption (e.g., diarrhea, ulcers, GI surgery, or other GI abnormalities).
- •(7)Has psychiatric disorder(s) or alcohol abuse that would interfere with consent, study participation, or follow up.
- •(8)Has uncontrolled congestive heart failure (CHF) or angina, including patients with a history of myocardial infarction within 2 months of enrollment, or patients with cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification.
- •(8)Has a systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment.
- •(9)Known human immunodeficiency virus (HIV) positivity.
- •(10)Has any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo chemotherapy.
- •(11)Patient is dependent on the investigator (e.g., family, relatives, employee…)
研究者
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