EUCTR2006-002221-23-FR进行中（未招募）不适用
An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MediGene AG
- 入组人数
- 135
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
- Female
入选标准
- •1. Histologically proven triple-receptor-negative metastatic or relapsed breast cancer
- •2. Patients must have received adjuvant or neoadjuvant chemotherapy containing an anthracycline regimen alone or in combination with a taxane containing regimen, i.e. a R0 resection status must have been achieved after initial diagnosis
- •3. Minimum interval after the end of adjuvant or neoadjuvant chemotherapy
- •anthracycline regimen alone = no chemotherapy free interval needed
- •taxane containing regimen = 6 months after end of chemotherapy
- •4. Tumor lesions measurable according to RECIST criteria
- •5. Gender: female
- •6. Age greater or equal to 18 years old
- •7. Negative pregnancy test (females of childbearing potential)
- •8. Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment
- •9. ECOG performance status 0, 1 or 2
- •10. Normal cardiac function (i.e. normal ECG, echocardiography or left ventricular ejection fraction and clinical examination)
- •11. Signed informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Chemotherapeutic treatment for relapsed/metastatic breast cancer before enrollment
- •2. Any radiotherapy for metastatic breast cancer before enrollment except for treatment of bone metastases or local recurrences if target lesions are not included in the irradiated field
- •3. Major surgery < 4 weeks prior to enrollment
- •4. Surgery of relapse resulting in a R0 resection status
- •5. Immunotherapy < 6 weeks prior to enrollment
- •6. Severe pulmonary obstructive or restrictive disease
- •7. Acute or chronic inflammation (autoimmune or infectious)
- •8. Laboratory tests (hematology, chemistry) outside specified limits:
- •WBC < or equal 3 x 10 EXP 9/L
- •ANC < or equal 1.5 x 10 EXP 9/L
- •Platelets < or equal 100 x 10 EXP 9/L
- •Hb < or equal 9.0 g/dl (< or equal 5.6 mmol/l)
- •PT/PTT > 1.5 x ULN
- •9. Pregnancy or nursing status
- •10. Positive HIV testing
- •11. Known hypersensitivity to any component of the EndoTAG-1 and/or taxane formulations
- •12. History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
- •13. Known cerebral metastasis
- •14. History of active or significant neurological disorder and/or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
- •15. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
研究者
相似试验
进行中（未招募）
不适用
An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patientsEUCTR2006-002221-23-BEMediGene AG135
进行中（未招募）
不适用
An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patientsFemale patients with triple negative breast cancerMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2006-002221-23-DEMediGene AG135
进行中（未招募）
不适用
A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy with or without Panitumumab as First-line Treatment of Subjects with Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects who Fail the Combination Chemotherapy Only Arm.Cancer of the Head and NeckMedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckEUCTR2007-005722-79-ATAmgen Inc110
进行中（未招募）
1 期
A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy with or without Panitumumab as First-line Treatment of Subjects with Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects who Fail the Combination Chemotherapy Only Arm.Cancer of the Head and NeckMedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckEUCTR2007-005722-79-FRAmgen Inc113
进行中（未招募）
不适用
A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy with or without Panitumumab as First-line Treatment of Subjects with Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects who Fail the Combination Chemotherapy Only Arm.Cancer of the Head and NeckMedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckEUCTR2007-005722-79-CZAmgen Inc110