A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment
试验速览
- 阶段
- 2 期
- 入组人数
- 99
- 试验地点
- 10
- 主要终点
- Disease Control Rate as defined by Percentage of patients experiencing a Complete Response or a Partial Response or a Stable Disease according to RECIST measured at 16 weeks after treatment initiation
研究概览
简要总结
TL-118 is an anti-angiogenic drug combination designed for the treatment of cancer. The investigational product Tl-118 comprises of four well-known active components. The therapy is administrated at a unique dosing regimen that was found to be effective and advantageous in terms of safety. The product is formulated as an oral suspension, conveniently administrated by the patients at home and not requiring medical staff assistance. This Phase II clinical trial aims to evaluate the efficacy, safety and tolerability of TL-118 in Gemcitabine treated Pancreatic Cancer patients
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
- 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 at least 18 years at enrollment.
- •Metastatic Pancreatic Cancer
- •The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
- •Patient has measurable disease by (RECIST).
- •Patient is starting standard of care Gemcitabine treatment
- •ECOG performance status ≤ 1
- •Adequate renal function
- •Adequate hepatic function
- •Adequate bone marrow reserve
- •Resolution of prior therapy acute adverse events.
- •Patient is capable of swallowing.
- •Patient's Informed Consent. -
排除标准
- •Hypersensitivity to one or more of the TL-118 active components
- •Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
- •CNS or Brain metastases
- •Prior systemic therapy for pancreas cancer
- •Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
- •Concurrent use of any other investigational product
- •Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
- •Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
- •Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
- •Circumstances likely to interfere with absorption of orally administrated drugs.
- •History of noncompliance to medical regimens or coexisting -
研究组 & 干预措施
TL-118 with standard of care Gemcitabine
干预措施: TL-118 (Drug)
Gemcitabine with out TL-118
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Disease Control Rate as defined by Percentage of patients experiencing a Complete Response or a Partial Response or a Stable Disease according to RECIST measured at 16 weeks after treatment initiation
时间窗: 16 weeks after treatment initiation
次要结局
- Quality of life(Baseline to study completion)
- Response Rate(Measured at week 16)
- Overall Survival(Measured at week 16 and 52)
- Progression free survival(Measured at week 16 and 52)