ISRCTN65084068已完成不适用
A phase I dose escalation study of intravesical TMX-101 in subjects with Non-Muscle-Invasive Bladder Cancer
Telormedix SA (Switzerland)0 个研究点目标入组 30 人开始时间: 2013年8月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •The study population will consist of patients with non-muscle invasive bladder cancer (NMIBC) who have undergone Transurethral resection (TUR). A complete TUR will be performed in patients entering the first part of the study, while in patients entering the second part of the study a marker lesion will be left for assessment after the TUR procedure.
- •All patients
- •1. Age = 18 years.
- •2. Performance status: ECOG 0-1.
- •3. Subjects who have read and understood the informed consent form and are willing and able to give informed consent. Subjects who fully understand the requirements of the trial and are willing to comply with all trial visits and assessments.
- •4. Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For the purposes of this trial, ?women of childbearing potential? is defined as: ?All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive?.
- •5. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to, during and four weeks after the last dose trial medication. ?Adequate contraception? is defined as follows: two barrier methods, or one barrier method with a spermicide or intrauterine device.
- •Patients to enter the first part of the study:
- •1. Histologically confirmed diagnosis of urothelial carcinoma of the urinary bladder stage Ta with low and high histological grade or T1 with low histological grade.
- •2. Complete removal of tumours through TUR procedure.
- •Patients to enter the second part of the study:
- •1. Histologically confirmed diagnosis of urothelial carcinoma of the urinary bladder stage Ta or T1 with low histological grade.
- •2. Prior to TUR, multiple tumours but not more than seven.
- •3. One marker lesion left for assessment after TUR procedure, between 0.5 to 1.0 cm in diameter, documented with video or photo.
排除标准
- •Patients in the first part of the study:
- •1. Current urinary tract T1 high grade tumour, previous or current history of carcinoma in situ, muscle invasive disease (T2 or higher).
- •2. Current high grade urinary cytology in subjects with T1 tumour.
- •Patients in the second part of the study:
- •1. Current urinary tract Ta high grade tumour, previous or current history of T1 high grade tumour, carcinoma in situ, muscle invasive disease (T2 or higher).
- •2. Current high grade urinary cytology
- •3. Subjects who require immediate complete TUR, as judged by the investigator.
- •All Patients
- •1. Any prior intravesical BCG or any other immunotherapy within the last 24 months.
- •2. Previous intravesical treatment with chemotherapy agents within 6 months of entry into the study.
- •3. Subjects who cannot hold instillation for at least one hour.
- •4. Subjects who cannot tolerate intravesical administration or intravesical surgical manipulation.
- •5. Current or prior pelvic external beam radiation or pelvic brachytherapy.
- •6. Existing urinary tract infections or recurrent severe bacterial cystitis.
- •7. History of disease of the upper urinary tracts (e.g. vesico-urethral reflux, indwelling urinary stent, UT stones).
- •8. Bone marrow impairment as evidenced by Haemoglobin < 9.0 g/dL, ANC 1.5 x 109/L, platelets < 120 x 109/L
- •9. Renal impairment as evidenced by serum creatinine > 1.5 x ULN, and/or calculated creatinine clearance < 60 mL/min.
- •10. Liver function abnormality as defined by total bilirubin > 1.5 x ULN, or AST/ALT > 2.5 x ULN.
- •11. Bleeding disorders as evidenced by INR > 1.5 x ULN.
- •12. Immunosuppressed patients or patients receiving immunosuppressive therapy or who are otherwise immunocompromised.
- •13. Known HIV positivity, active hepatitis C, or active hepatitis B.
- •14. Any other active malignancy within 5 years except study indication, basal or squamous cell skin cancers and cured prostate cancer (PSA below 0.2 ng/mL).
- •15. Clinically significant active infections within 4 weeks before initial treatment administration.
- •16. Any medical or psychiatric condition which, in the opinion of the investigator, might impair the subject?s well being or preclude him from adhering to the protocol or completing the trial as per protocol.
- •17. Suspected hypersensitivity to imidazoquinoline compounds, poloxamer 407, hydroxy propyl betacyclodextrin, lactic acid.
- •18. Women who are pregnant or breast feeding.
- •19. Participation in any other protocol involving administration of an investigational agent within 3 months prior to entering this study.
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