NCT03002805Unknown1 期
A Phase I Trial of CBT-1® in Combination With Doxorubicin in Patients With Locally Advanced or Metastatic, Unresectable Sarcomas Previously to Have Progressed on 150 mg/m2 or Less of Doxorubicin
CBA Research12 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年3月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 46
- 试验地点
- 12
- 主要终点
- Maximum tolerated dose of CBT-1® when combined with doxorubicin
研究概览
简要总结
This study evaluates the combination of CBT-1® and doxorubicin for the treatment of metastatic, unresectable sarcoma in patients who have progressed after treatment with 150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day cycle, as well as doxorubicin on days 5 and 6.
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
- •Age ≥ 18 years
- •Locally advanced or metastatic, unresectable sarcoma that has progressed after treatment with 150 mg/m2 or less of doxorubicin or anthracycline equivalent
- •Measurable disease by RECIST 1.1
- •ECOG performance status of ≤ 1
- •Life expectancy of > 3 months
- •Able to swallow pills
- •Adequate bone marrow and organ function as defined as:
- •Hemoglobin > 9 g/dl
- •Absolute neutrophil count ≥ 1,500/mcL
- •Platelets ≥ 100,000/mcL
- •Total bilirubin < 1.5 X ULN
- •AST(SGOT)/ALT(SGPT) ≤3 X ULN (including patients with liver metastases)
- •Creatinine <1.5 X ULN
- •Cardiac ejection fraction >50% (by echocardiogram or MUGA) within 15 days of enrollment
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment.
- •Participants must be willing and able to comply with the study scheduled visits, laboratory tests, and other procedures outlined in the protocol.
- •Pre-menopausal women must have a negative pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant, double barrier and/or complete abstinence (non-periodic).
- •Washout period prior to Day 1 Cycle 1:
- •3 weeks since last chemotherapy or therapeutic radiation therapy
- •4 weeks or 3 half-lives since prior antibody-based therapy, whichever is shorter
- •2 weeks since any oral anti-neoplastic or oral investigational agent
- •Resolution of treatment-related toxicity to < grade 1; alopecia and cutaneous toxicity are allowed < grade 2
- •>1 week since palliative RT
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Prior exposure to CBT-1
- •Previously untreated sarcomas
- •Low-grade sarcomas as well as alveolar soft parts sarcoma, clear cell sarcoma, extraskeletal myxoid chondrosarcoma, well-differentiated liposarcoma, gastrointestinal stromal tumor, chordoma
- •Participants receiving other investigational agents
- •Participants with known uncontrolled brain metastases
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic indwelling drains, history of interstitial pneumonitis or pulmonary fibrosis or psychiatric illness/social situations that would limit compliance with study requirements
- •Actively breastfeeding women unless it is interrupted during treatment and at least 6 weeks after treatment discontinuation
结局指标
主要结局
Maximum tolerated dose of CBT-1® when combined with doxorubicin
时间窗: 3 years
次要结局
- Overall Response Rate(3 years)
- Disease Control Rate (DCR) of CBT-1® when combined with doxorubicin(week 12)
- Recommended phase 2 dose (RP2D) of CBT-1® when combined with doxorubicin(3 years)
研究者
研究点 (12)
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