Phase 2a, Multi-center, Placebo-controlled, Randomized, Partially Blinded, Study Infused TK112690 or or Placebo Administered Along With Methotrexate Weekly for Four Consecutive Weeks to Patients With Recurrent or Residual SCCHN
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Tosk, Inc.
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Mucositis
研究概览
简要总结
Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion along with a nutritional supplement administered two hours before the methotrexate. One hour before the methotrexate treatment the patients will be administered the first infusion of the day of either TK112690 or placebo depending on randomization. Five hours after the methotrexate treatment the patients will be administered the second treatment of either TK112690 or placebo depending on randomization. The TK112690 dose will be 45 mg/kg.
详细描述
Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion along with a nutritional supplement administered two hours before the methotrexate. One hour before the methotrexate treatment the patients will be administered the first infusion of the day of either TK112690 or placebo depending on randomization infusion. Five hours after the methotrexate treatment the patients will be administered the second treatment of either TK112690 or placebo depending on randomization. The TK112690 dose will be 45 mg/kg.
- A total of 22 patients will be enrolled into one of 2 different dose groups: TK-112690 treated or placebo treated.
- Screening must be within 15 days of subject enrollment.
- Patients will remain for observation at the clinical site for a minimum of 25 hours post initial TK112690 or placebo dose.
- Study follow-up will occur on Week 6, two weeks after the last dosing of methotrexate.
- Blinding: The study will be partially blinded. The patient and investigator will be blinded as to whether TK112690 or placebo is administered. The CRO, sponsor, and site pharmacist will know whether the patient was administered active drug or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study will be partially blinded. The patient and investigator will be blinded as to whether TK112690 or placebo is administered. The clinical research organization, sponsor, and site pharmacist will know whether the patient was administered active drug or placebo.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subject has not failed at least one courses of non-MTX chemotherapy or one course of non-MTX chemotherapy and chemo radiation for treating their SCCHN.
- •Uncontrolled active infection.
- •Current mucositis (>Grade 1).
- •Pregnant or nursing mother.
- •Prior history of a cerebrovascular accident or hemorrhage.
- •Congestive heart failure, as defined by New York Heart Association class III or IV.
- •Uncontrolled hypertension.
- •Active psychiatric/mental illness making informed consent or useful clinical follow-up unlikely.
- •Subjects who have previously been enrolled into this study and subsequently withdrew.
- •Subject receiving other investigational agent(s).
- •Any systemic immunosuppressive medication/therapy (eg, other chemotherapy, steroids).
- •Any significant systemic illness, unstable or severe medical condition(s) that could put the subject at risk during the study, interfere with outcome measures, or affect compliance with the protocol procedures such as intercurrent infection and/or autoimmune disease, ie, any condition that compromises the immune system.
- •Known or suspected intolerance or hypersensitivity to the study materials (TK-112690 and/or excipients or closely related compounds).
- •Subjects, who have received, or plan to receive, radiation or chemotherapy within 4 weeks of screening.
- •Subjects that have a history of poor compliance in clinical research studies.
- •Subjects that have participated in any other investigative clinical trial in the past 4 weeks.
研究组 & 干预措施
TK112690
TK112690 treatment
干预措施: TK-112690 (Drug)
Placebo
TK112690 formulation
干预措施: Placebo TK-112690 (Drug)
结局指标
主要结局
Mucositis
时间窗: up to 4 Weeks
Mucositis Evaluation Using Established Scoring Systems: NCI/CTCAE at 4 WKs (Primary) and WHO at 4 WKs (Primary). NCI/CTCAE=National Cancer Institute/Common Terminology Criteria for Adverse Events and WHO=World Health Organization NCI Grades- 0= No mucositis, 1=Mild mucositis (Painless ulcers, erythema, or mild soreness in the absence of lesions), 2=Moderate mucositis (Painful erythema, edema, or ulcers but eating or swallowing possible), 3= Severe mucositis (Painful erythema, edema, or ulcers requiring IV hydration), 4=Life threatening, 5=Death WHO Grades- 0=No mucositis, 1= Mild (Oral soreness, erythema), 2=Moderate (Oral erythema, ulcers, solid diet tolerated), 3=Severe (Oral ulcers, liquid diet only), 4=Life-threatening (Oral alimentation impossible). For both the scales above, a higher score implies greater mucositis. Scale specific mean values for patients in each group (placebo or treated) are calculated and compared by Student's t-test.
次要结局
- Incidence Adverse Events That Are Related to Treatment(Measured Weekly Over 4 Weeks of Study)