CTRI/2022/06/043202已完成2 期
A Phase 2a, multi-center, placebo-controlled, randomized, assessor blind study ofbolus 5-fluorouracil and infused leucovorin plus either infused TK 90 for parenteral use or infused TK 90 placebo administered weekly for 6 consecutive weeks to patients with colorectal cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Tosk Inc
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- A) SOM (Severe Oral Mucositis) - Comparison of incidences of Grade 3 or 4 mucositis (WHO scale) in the treatment (TK-90) and TK-90 placebo groups. B) Duration of SOM - Days patients suffer Grades 3 and 4 oral mucositis measured by WHO scale from the start of treatment; number of days from the first occurrence of WHO Grade 3 or 4 OM through the first occurrence of non-severe (≤ Grade 2) without a subsequent instance of ≥ Grade 3 OM. patients with complete study follow-up for severe OM who do not develop severe OM (grade 0-2) will be considered to have durations of 0 days.
研究概览
简要总结
5-FU, a structural analogue of uracil, is used as achemotherapeutic agent for various malignancies including CRC. One of the majortoxic effects of 5-FU is intestinal injury, apparently mediated by both thedirect effect of 5-FU, and an indirect effect produced by infiltration of gutbacteria and gut bacteria-associated toxins into systemic circulation throughthe impaired mucosal barrier.
TK-90 for parenteral use, is a novel, non-toxic and specifictherapy to prevent and treat mucositis, a major side effect of 5-FU.
Thisstudy is designed primarily to establish, in a placebo- controlled trial, pilotefficacy compared to placebo, and secondarily to confirm the safety andtolerability of TK-90 when administered weekly for 6 weeks along with 5-FU/LVto patients with local, advanced, recurrent, metastatic CRC. Success willjustify exploration of use of TK-90 with other cytotoxics besides MTX and 5-FU,radiation therapy, and other treatments that are known to cause mucositis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients 18 to 75 years old (both inclusive) with a histologically or cytological confirmed diagnosis of colorectal cancer
- •Patient scheduled to receive bolus 5 FU along with LV as first line or subsequent therapy for treating locally advanced or residual or recurrent or metastatic colorectal cancer.
- •No prior systemic treatments for cancer (chemotherapy and/or radiotherapy) 4 weeks prior to screening.
- •Be able to read and understand and provide a signature or thumb impression on the Informed Consent Form (ICF) before entering the study.
- •No other concurrent, active, invasive malignancy.
- •ECOG performance status of 0 to
- •Must have a life expectancy of at least 6 months.
- •No active angina or uncontrolled arrhythmia.
- •Not pregnant or nursing. Women of childbearing potential must have a negative serum pregnancy test at screening and on the day before dosing and must use medically acceptable methods of birth control. Acceptable methods of birth control include oral or transdermal contraceptives, condoms, spermicidal foam, IUD, progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or post-menopausal for more than or equal to 1 year, must be specified in the patient’s medical history file and CRF.
- •Mucositis Grade less than or equal to 1 per WHO Scale and Xerostomia of Grade less than or equal to 2 per CTCAE
- •Adequate bone marrow function as per CTCAE V5, defined as follows: i) Absolute neutrophil count more than or equal to 1500 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization ii) Platelets more than or equal to 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization iii) Hemoglobin more than or equal to 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to randomization (Note: The use of transfusion or other intervention to achieve Hgb more than 8.0 g/dl is acceptable).
- •Adequate hepatic function with bilirubin less than or equal to 1.5 x upper-normal limit (ULN), AST or ALT less than or equal to 3 x ULN within 2 weeks prior to randomization
- •Adequate renal function with serum creatinine less than 1.5 mg/dl and creatinine clearance (CrC) more than or equal to 50 ml/min within 2 weeks prior to randomization determined by 24-hour collection or estimated by Cockcroft-Gault formula. CrC male is equal to [(
- •age) x (wt in kg)] / [(Serum Cr mg/dl) x (72)]. CrC female is equal to 0.85 x (CrCl male)
- •Normal serum calcium or normal corrected serum calcium within 2 weeks prior to randomization; formula for corrected calcium if albumin valued is below normal range: Corrected calcium (mg/dl) is equal to (
- •[patients albumin (g/dl)] x 0.8) + patient measured calcium (mg/dl).
排除标准
- •An active infection including HIV/ HBV/ HCV infection.
- •Patients who have not fully recovered after prior surgery.
- •(Patients who have had prior surgery and have fully recovered and patients who may have surgery in the future are eligible.)
- •Unstabilized or symptomatic brain metastasis (History of brain metastases allowed if disease has stabilized or improved after radiation and/or craniotomy).
- •Pregnant or nursing mother.
- •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.
- •Patients who have previously been enrolled into this study and subsequently withdrew.
- •Patient receiving other investigational agent(s).
- •Any systemic immunosuppressive medication/therapy (eg, other chemotherapy, steroids).
- •Any prohibited prior or concomitant therapy 2 weeks prior to enrollment.
- •Presence of any significant systemic illness, unstable or severe medical condition(s) that could put the patient 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 90 and/or excipients or closely related compounds).
- •Patients that have a history of poor compliance in clinical research studies.
结局指标
主要结局
A) SOM (Severe Oral Mucositis) - Comparison of incidences of Grade 3 or 4 mucositis (WHO scale) in the treatment (TK-90) and TK-90 placebo groups. B) Duration of SOM - Days patients suffer Grades 3 and 4 oral mucositis measured by WHO scale from the start of treatment; number of days from the first occurrence of WHO Grade 3 or 4 OM through the first occurrence of non-severe (≤ Grade 2) without a subsequent instance of ≥ Grade 3 OM. patients with complete study follow-up for severe OM who do not develop severe OM (grade 0-2) will be considered to have durations of 0 days.
时间窗: 48 Hr and 96 hr every week upto week 06 and at week 08
次要结局
- A) In addition to the WHO scale, mucositis status in the patients will also be evaluated using two different published and validated mucositis scales: NCI/CTCAE/mucositis, and PROMS.(B) Comparison of WHO scale values of treated patients at each point of evaluation.)
研究者
研究点 (7)
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