CTRI/2021/07/035257尚未招募1 期
An open label, multicentric study to determine the maximum tolerated dose (MTD) and plasmapharmacokinetics of Oral Cabazitaxel Lipid tablet in patients with advanced solid tumors who havefailed conventional therapy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
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
入选标准
- •1. Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial.
- •2. Male or female patients with age greater than or equal to 18 years to less than or equal to 65 years at the screening visit.
- •3. Patients with histopathologically/cytologically confirmed following primary advanced solid tumors- Breast cancer, Head and neck, Lung, Melanoma, gastric, colon or Prostate for which Cabazitaxel monotherapy is a viable treatment option.
- •4. Patients with advanced solid malignancies refractory to conventional treatment.
- •5. Patient with an ECOG performance status of 0-2.
- •6. Patient must have an adequate bone marrow, renal and hepatic function
- •7. Patient should be able to comply with study procedures in the opinion of the investigator.
- •8. Life expectancy should be greater than 2 months
- •9. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to Study drug administration) sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
- •10. In case of Male patients- Either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug or till next chemotherapy cycle.
- •It is investigators responsibility to ensure that above points regarding an effective method of avoiding pregnancy with patient in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol.
排除标准
- •1. Known hypersensitivity or intolerance to Cabazitaxel or any of its excipients or related group of drugs such as Docetaxel and Paclitaxel.
- •2. If the patient had undergone prior surgery, radiation, chemotherapy, or other anticancer therapy within 4 weeks (28 days) prior to dosing in the study
- •3. Patients with known human immunodeficiency virus (HIV) infection.
- •4. A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- •5. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 1 year before Screening.
- •6. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
- •7. Any other condition or abnormal baseline findings that, in the investigators judgement might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •8. 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.
- •9. Patient with a history of difficulty in donating blood or difficulty in accessibility of veins.
- •10. Patient with known active central nervous system metastases and or or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 28 days prior to trial treatment.
- •This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- •11. Patients with prior extensive radiotherapy (greater than 20 percent of bone marrow area) as per the documented medical history
- •12. Abnormal cardiac condition as mentioned below:
- •Ã¢â?¬Â¢Uncontrolled cardiac arrhythmias,
- •Ã¢â?¬Â¢Angina pectoris, and or or hypertension,
- •Ã¢â?¬Â¢History of congestive heart failure within last 6 months
- •Ã¢â?¬Â¢History myocardial infarction within last 6 months.
- •Ã¢â?¬Â¢Left ventricular ejection fraction less than or equal to 50 percent by echocardiogram
- •13. Patient with Uncontrolled diabetes mellitus as (defined as HbA1c greater than or equal to 8 percent as per ADA) active uncontrolled gastroesophageal reflux disease (GERD) or with active
- •infection requiring systemic antibiotic or anti-fungal medication
- •14. Concurrent or planned treatment with strong inhibitors or inhibitors of Cytochrome P450 3A4 or 5. A one-week washout period will be required for patients who were already on these treatments.
研究者
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