CTRI/2025/04/083831尚未招募2/3 期
A prospective, Multicenter, Open-label, Non-randomized, Acceptability Study of Cyclophosphamide Powder for Oral Solution 30 mg/ mL, (Manufactured by Intas Pharmaceuticals Limited, India) in Paediatric Cancer Patients who are on Oral Cyclophosphamide Treatment
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 11
- 主要终点
- To evaluate the overall acceptability of Cyclophosphamide Powder for Oral Solution
研究概览
简要总结
This is a acceptability study which will be conducted in Paediatric Cancer Patients who are on Oral Cyclophosphamide Treatment to evaluate the overall acceptability and evaluate the taste and smell acceptability of Cyclophosphamide Powder for Oral Solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female paediatric subjects from 3 to less than 18 years at the time of signing consent.
- •Subjects with documented histologically or cytologically confirmed malignant disease requiring cyclophosphamide treatment (oral cyclophosphamide as monotherapy or as part of combination therapy) and who are already receiving Cyclophosphamide by dissolving/crushing the tablet.
- •Able to give assent for participation in the trial based on their mental ability/actual age.
- •Moreover parents/care givers/legally-authorized representatives (LAR) have to give written informed consent for respective subjects.
- •Such parents/care givers/LARs should be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- •For illiterate individuals, verbal consent should be obtained in the presence of and be countersigned by a literate witness.
- •If subjects are already on radiotherapy, a gap of 28 days (4 weeks) must be maintained between the last day of radiotherapy and the day of screening.
- •A life expectancy of at least 3 months.
- •Recovery from any toxic effects of previous chemotherapy as judged by the Investigator at the time of screening.
- •Able to intake food and medication at the time of screening.
- •Karnofsky Performance Score greater than 50 for subjects greater than or equal to 16 to less than 18 years of age OR Lansky score greater than 50 for subjects greater than 3 to less than 16 years of age.
- •Adequate bone marrow function, renal function and hepatic function at the screening visit.
- •A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 12 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of at least 12 months after the last dose of study intervention.
- •The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- •• A WOCBP must have a negative serum pregnancy test at screening; and negative urine pregnancy test before the first dose of study intervention at baseline visit.
- •• If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
- •In such cases, the subject must be excluded from participation if the serum pregnancy result is positive.
- •• Additional requirements for pregnancy testing during and after study intervention are located in Appendix 8.2.
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
排除标准
- •Known hypersensitivity to study drugs or any of ingredients of the formulation.
- •Subject in need of receiving the study medication via nasogastric tube.
- •Any other condition that, in the investigator’s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •The receipt of an investigational medicinal product within a period of 30 days prior to the first dose of investigational medicinal product for the current study.
- •Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
- •Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
- •Female subjects of childbearing potential with positive serum beta-human chorionic gonadotropin (beta-hCG) at the time of screening.
- •Pregnant or lactating subject.
- •Subjects or their caregivers unable to carry out study assessments and comply with the requirements of the protocol.
- •Currently known active case of positive for COVID-19 infection.
- •Active ulceration of the oral mucosa.
结局指标
主要结局
To evaluate the overall acceptability of Cyclophosphamide Powder for Oral Solution
时间窗: Overall acceptability will be assessed according to the rating scales, within 10 minutes after dosing
次要结局
- To evaluate the taste and smell acceptability of Cyclophosphamide Powder for Oral Solution(Taste and smell acceptability will be assessed according to the rating scales, within 10 minutes after dosing)
研究者
Dr Naman Shah
Lambda Therapeutic Research Ltd
研究点 (11)
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