EUCTR2006-002221-23-BE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
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. Minimum interval of 6 months after the end of any previous
- •taxane-containing chemotherapy regimen
- •3. At least one tumor lesion measurable according to RECIST
- •4. Gender: female
- •5. Age equal or mayor 18 years old
- •6. Negative pregnancy test (females of childbearing potential)
- •7. Willingness to perform double-barrier-contraception during studyand for 6 months post chemotherapy treatment
- •8. ECOG performance status 0, 1 or 2
- •9. 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. More than 1 previous chemotherapeutic treatment for metastatic
- •or relapsed disease
- •2. Major surgery < 4 weeks prior to enrollment
- •3. Immunotherapy < 2 weeks prior to enrollment
- •4. Severe pulmonary obstructive or restrictive disease
- •5. Uncontrolled inflammatory disease (autoimmune or infectious)
- •6. Clinically significant cardiac disease (NYHA stadium > 2)
- •7. Laboratory tests (hematology, chemistry) outside specified limits:
- •WBC < 3 x 109/L
- •ANC = 1.5 x 109/L
- •Platelets = 100 x 109/L
- •Hb = 9.0 g/dl (= 5.6 mmol/l)
- •PTT/ INR > 1.5 x ULN
- •AST or ALT > 2.5 x ULN
- •Alkaline Phosphatase > 2 x ULN
- •Total Bilirubin > 1.5 x ULN
- •8. Pregnancy or nursing status
- •9. Known positive HIV testing
- •10. Known hypersensitivity to any component of the EndoTAG-1 or
- •taxane formulations
- •11. History of malignancy other than breast cancer < 5 years prior to
- •enrollment, except skin cancer (i.e. basal or squamous cell
- •carcinoma) treated locally
- •12. Known progressive cerebral metastasis (patients with cerebral
- •metastases in a stable state or after successful surgical or
- •radiological treatment are allowed to participate in the study)
- •13. History of active or significant neurological disorder 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
- •14. 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 patientsFemale patients with triple negative breast cancerMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2006-002221-23-FRMediGene 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