NCT02994498尚未招募1 期
An Open-Label Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of DCB-BO1301 as Add-on Therapy to Dacarbazine in Subjects With Advanced Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 33
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The primary study objectives are
- to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects with advanced melanoma (Phase I)
- to evaluate the efficacy profile of DCB-BO1301 at MTD or lower dose level as add-on therapy to dacarbazine in subjects with advanced melanoma in terms of progression free survival (Phase IIa)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≧ 20 years old (inclusive)
- •Histologically or cytologically confirmed advanced melanoma, (stage III or IV)
- •Subject must have at least one of the following:
- •Melanoma that was previously treated with at least one complete or partial course of therapy for melanoma with either a poor to no response or evidence of disease progression;
- •Melanoma that cannot be treated with first-line therapies because of medical comorbidities/risk of toxicity; or
- •Melanoma that has not been treated with first-line therapies because of patient refusal.
- •If melanoma is possibly resectable, the melanoma must have recurred despite at least two attempts at resection.
- •Evaluable disease, at least one measurable target lesion on imaging by RECIST 1.1 criteria on previous scan
- •ECOG performance status ≤ 2 and life expectancy ≥ 3 months Note: ECOG = Eastern Cooperative Oncology Group
- •Females subjects must be either
- •of non-childbearing potential:
- •Or, if of childbearing potential:
- •Must have a negative urine or serum pregnancy test at screening, and
- •If heterosexually active, must use at least 1 form of birth control (which must be a barrier method) starting at screening and through the primary study period.
- •Female subject must not be breastfeeding at screening, through the treatment period and through the primary study period.
- •Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening, through the treatment period and through the primary study period.
- •Dated and signed informed consent
排除标准
- •Primary CNS malignancies or clinically active CNS metastases
- •Ascertained hypersensitivity to any component of investigational product or standard therapies that the subject will be treated
- •Any of the following hematologic abnormalities:
- •Hemoglobin < 10 g/dL,
- •ANC < 1,500/μL,
- •Platelets < 75,000 /μL Note: ANC = absolute neutrophil count
- •Any of the following serum chemistry abnormalities:
- •Total bilirubin > 1.5 × ULN,
- •AST, ALT, or Alk-P > 2.5 × ULN,
- •serum albumin < 2.5 g/dL,
- •creatinine > 1.5 × ULN,
- •creatine phosphokinase (CPK) > 2.5 × ULN,
- •d. any other ≥ Grade 3 laboratory abnormality at baseline (other than those listed above) Note: ULN = upper limit of normal. AST = aspartate transaminase, ALT = alanine transaminase
- •History of known brain metastases
- •Anticipated requiring, being taking, or taken with past 2 weeks of Screening visit of systemic steroid, immunosuppressive agents, aspirin (more than 100 mg/day), NSAID (except COX-2 Inhibitors), heparin, low molecular weight heparin or warfarin (more than 1 mg/day) Note: NSAID = Nonsteroidal anti-inflammatory drugs
- •Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral DCB-BO1301 treatment
- •Serious/active infection such as HIV, HBV or HCV carrier, or infection requiring parenteral antibiotics Note: HIV = Human immunodeficiency virus; HBV = Hepatitis B virus; HCV = hepatitis C virus
- •Uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing
- •Consumption of herbal preparations/supplements (except for a daily multivitamin/mineral supplement not containing herbal components) within 2 weeks prior to the start of DCB-BO1301 administration
- •Significant cardiovascular disease, including:
- •Active clinically symptomatic left ventricular failure
- •Active hypertension (diastolic blood pressure > 100 mmHg). Subjects with a history of hypertension must have been on stable doses of anti-hypertensive drugs for ≥ 4 weeks prior to start of DCB-BO1301 administration
- •Uncontrolled hypertension: Blood pressure >140/90 mmHg on more than 2 antihypertensive medications
- •Myocardial infarction within 3 months prior to the start of DCB-BO1301 administration
- •Prothrombin time > 1.5 x ULN; APTT abnormal (< 20 sec or > 34 sec) ; long QT syndrome
- •Significant gastrointestinal disorder(s) that would, in the opinion of the investigator, prevent absorption of an orally available agent
- •Has received an investigational agent within 4 weeks of entering this study
- •With any condition judged by the investigator that entering the trial may be detrimental to the subject
- •Receiving chemotherapy, investigational or hormonal therapy, major surgeries in the previous 4 weeks of Screening visit.
研究组 & 干预措施
DCB-BO1301 1 capsule
Experimental
DCB-BO1301 1 capsule, tid (around 1 hour before meal) for at most 48 weeks
干预措施: DCB-BO1301 (Drug)
DCB-BO1301 2 capsules
Experimental
DCB-BO1301 2 capsules, tid (around 1 hour before meal) for at most 48 weeks
干预措施: DCB-BO1301 (Drug)
DCB-BO1301 3 capsules
Experimental
DCB-BO1301 3 capsules, tid (around 1 hour before meal) for at most 48 weeks
干预措施: DCB-BO1301 (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: Week 6
次要结局
- Incidence of adverse events(Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52)
- Response rate(Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52)
- Overall survival(Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52, 64, 76)
- Changes in global health/QoL standardized score at post-treatment visits compared to baseline.(Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52)
- Progression free survival(Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52, 64,76)
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