EUCTR2013-003252-20-BE进行中（未招募）1 期
An open-label, two-stage Phase I/IIa dose escalation study of BT062 in metastatic triple receptor-negative breast cancer and in metastatic transitional cell carcinoma of the urinary bladder - INTRAIN-BB (INdaTuximab RAvtansin effect IN Brest and Bladder cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed written Informed Consent Form in accordance with institutional guidelines and applicable national law, prior to any study-related procedure;
- •2. Diagnosis:
- •metastatic triple-negative breast cancer with histochemical confirmation of the absence of progesterone receptors, estrogen receptors and human epidermal growth factor receptors
- •metastatic transitional celll carcinoma of the urinary bladder
- •3. Relapsed or relapsed / refractory disease at a stage that cannot be controlled adequately by surgery, radiotherapy or standard chemotherapy;
- •3a: Patients presenting with triple negative breast cancer and who failed at least 2, but not more than 4 previous chemotherapy / drug therapy regimens. In patients who failed more than 2 prior chemotherapy / drug therapy regimens, the last progression of disease must not have been observed earlier than within 9 weeks of the start of the treatment.
- •3b: Patients presenting with urinary bladder cancer and who failed at least 1, but not more than 2 previous chemotherapy regimens.
- •4. Measurable disease according to the RECIST (v1.1) with at least one measurable lesion and at least one tumor biopsy with histologically confirmed malignancy;
- •5. Histological confirmation of moderate to high CD138 expression for at least one lesion;
- •6. Female or male patients aged > 18 years;
- •7. Estimated life expectancy = 12 weeks;
- •8. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2;
- •9. Absolute neutrophil count (ANC) = 1500 cells / µL;
- •10. Hemoglobin (Hb) = 9.0 g / dL;
- •11. Platelet count = 100,000 / µL at screening;
- •12. Liver transaminases:
- •In patients without liver metastases: AST (SGOT) and ALT (SGPT) = 3 times the upper limit of normal (ULN);
- •In patients with liver metastases: AST (SGOT) and ALT (SGPT) = 5 times the ULN, provided that there is no evidence of other reasons for transaminase level increase,
- •13. Total bilirubin = 1.5 times the ULN;
- •14. Lipase = 3 times the ULN;
- •15. Renal function:
- •Serum creatinine = 2 mg / dL; Creatinine clearance (CRCL) = 50 mL / min;
- •16. Ability to understand, and willingness to sign a written Informed Consent Form;
- •17. Ability and willingness to adhere to the study visit schedule and all protocol procedures;
- •18. Subjects must use two acceptable methods of birth control from the point of signing Informed Consent Form (ICF) until 3 months after administration of the last dose of study drug;
- •19. Patients must agree not to donate blood from the point of signing the ICF until at least 1 month after administration of the last dose of the study drug;
- •20. Negative serum or urine pregnancy test in female patients of childbearing potential.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. History of allergy against study drug related components or drugs
- •2. Administration of chemotherapy or radiotherapy within 3 weeks prior to day of first dose of study drug or during the study;
- •3. Chemotherapy with nitrosoureas or mitomycin C within 6 weeks prior to day 1
- •4. Antineoplastic therapy with biological agents within 2 weeks before day 1 or within 5 drug half-lifes (t½) prior to first dose, whichever time period is longer
- •5. Participation in an investigational therapeutic study within 3 weeks or within 5 drug half-lives (t1/2) prior to first dose, whichever time is longer.
- •6. Treatment with BT062 in previous studies;
- •7. Previous treatment with vinflunine;
- •8. Planned tumor-reduction surgery and surgical removal of well accessible metastases;
- •9. Anticipation of the need to apply radiotherapy during the first 3 cycles/12 weeks of the study.
- •10. Major surgery within 4 weeks prior to Day 1;
- •11. Persistence of clinically relevant symptoms of incomplete recovery from a previous major surgery;
- •12. Malignancy (other than the trial indications) within the past three years except:
- •Treated non-melanoma skin cancer;
- •Carcinoma in-situ of the cervix uteri;
- •Prostate carcinoma (Gleason Grade = 6) with stable prostate specific antigen (PSA) levels
- •13. Active metastasis of the central nervous System
- •14. In patients of the dose escalation part (first part) of the study: treatment with denosumab within 5 months before the first dose of BT062 and / or planned treatment with denosumab and time during the treatment with BT062.
- •15. In patients in the phase II part of the study who are scheduled to continue an ongoing denosumab treatment as a concomitant medication during the BT062 regimen:
- •a) treatment with denosumab that started less than 6 months before the first dose of BT062
- •b) changes in the denosumab dose level of more than 33% in the monthly dose in the last 3 months.
- •c) history of severe hypercalcemia or hypocalcemia (of any origin)
- •d) history of severe hypokalemia or severe hyperkalemia (of any origin)
- •e) history of osteonecrosis (of any origin)
- •f) history of severe adverse reactions that were assessed as related to denosumab
- •g) history of severe pain that was assessed as related to denosumab
- •h) history of hypersensitivity reactions to denosumab or any of its excipients
- •16. Acute or clinically relevant abnormalities in electrocardiogram (ECG);
- •17. Significant cardiac disease(= 6 months prior to Day 1)
- •18. Uncontrolled hypertension (recurrent or persistent increases in systolic blood pressure = 180 mm Hg or diastolic blood pressure = 110 mm Hg),
- •19. History of clinically significant drug or alcohol abuse or ongoing clinically significant alcohol or drug abuse;
- •20. Unwillingness or inability to adhere to the requirements of the study;
- •21. Serious psychiatric or any other medical condition (including laboratory abnormalities), that could interfere with treatment and puts the patient at an unacceptable risk;
- •22. Subject is a pregnant or nursing woman or is considering becoming pregnant during the study
- •23. Subject is a woman of childbearing potential (unless surgically sterile or post-menopausal > 52 weeks) who is not using two independent effective contraceptive methods during the study
- •Subject is a man and is not vasectomized or is not using two independent effective contraceptive methods during the study
研究者
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