EUCTR2016-000485-34-GB进行中（未招募）1 期
A randomized Phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (TAPPAS)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 128
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. Histologically-confirmed angiosarcoma that is not amenable to curative intent surgery (e.g., metastatic or bulky disease and disease for which surgical resection would carry an unacceptable risk to the patient). Pathology report will be reviewed by sponsor prior to randomization.
- •2. Documented progression on or following most recent systemic chemotherapy regimen (not required for chemotherapy-naïve patients), within 4 months prior to screening
- •3. Measurable disease by RECIST v1.1
- •4. Age of 18 years or older; in addition, patients age 12 to 17 years may enroll beginning in Cohort 2 if weight = 40 kg
- •5. Eastern Cooperative Oncology Group (ECOG) performance status = 1
- •6. Resolution of all acute AEs resulting from prior cancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) grade = 1 or to that patient’s pre-study baseline (except alopecia or neuropathy)
- •7. Adequate organ function as defined by the following criteria:
- •Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT])
- •and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) = 2.5 x upper limit of normal (ULN) or = 5 x ULN in cases of liver metastases
- •Total serum bilirubin = 1.5 x ULN
- •Absolute neutrophil count (ANC) = 1500/µL
- •Platelets = 100,000/µL (without transfusion support within 28 days prior to randomization)
- •Hemoglobin = 9.0 g/dL (without transfusion support within 14 days prior to randomization; erythropoietin or darbepoetin permitted)
- •Serum creatinine = 1.5 times the upper limit of normal or creatinine clearance > 30 mL/min by Cockcroft-Gault formula
- •International normalized ratio (INR) = 1.2 unless the patient is receiving a direct Factor Xa inhibitor
- •8. Willingness and ability to consent (and assent if under age 18) for self to participate in study
- •9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •10. Angiosarcoma tumor specimen, if available
- •11. Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) OR agree to use a condom with spermicide and to not donate sperm during the study and for at least 180 days following last dose of TRC105 or pazopanib
- •12. Woman of non-child bearing potential due to surgical sterilization (at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause (i.e., no menstrual bleeding for more than 12 months in a 1 or to that patient’s pre-study baseline (except alopecia or neuropathy) women aged 45 years or more), OR woman of child bearing potential who test negative for pregnancy at time of enrollment based on serum pregnancy test and agree to use at least 2 acceptable methods of birth control, one of which must be highly effective, during the study and for at least 180 days after stopping TRC105 or pazopanib
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. Prior treatment with TRC105
- •2. Prior treatment with any VEGF inhibitor
- •3. More than two prior lines (may be combination regimens) of chemotherapy for angiosarcoma (neoadjuvant/adjuvant treatment does not count as a line of treatment)
- •4. Current treatment or participation on another therapeutic clinical trial
- •5. Women who are pregnant or breastfeeding
- •6. Receipt of systemic anticancer therapy, including investigational agents, within 5 times the agent’s elimination half-life or 14 days of starting study treatment, whichever is shorter
- •7. Major surgical procedure or significant traumatic injury within 4 weeks prior to randomization and must have fully recovered from any such procedure or injury; planned surgery (if applicable) or the anticipated need for a major surgical procedure within the next six months. Note: the following are not considered to be major procedures and are permitted up to 7 days before randomization: Thoracentesis, paracentesis, laparoscopy, thoracoscopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, and imaging-guided biopsy for diagnostic purposes
- •8. Patients who have received wide field radiotherapy = 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to randomization
- •9. Uncontrolled hypertension defined as systolic > 150 or diastolic > 100 mm Hg on the average of the 3 most recent BP readings. Anti-hypertensives may be started prior to randomization.
- •10. Ascites or pleural effusion requiring intervention or that required intervention or recurred within three months prior to randomization
- •11. Pericardial effusion (except trace effusion identified by echocardiogram) within three months prior to randomization
- •12. History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for at least 28 days prior to randomization
- •13. Angina, myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism , pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within 6 months prior to randomization. Deep venous thrombosis within 3 months prior to randomization unrelated to a central venous catheter, unless the patient is anti-coagulated without the use of warfarin for at least 2 weeks prior to randomization. In this situation, low molecular weight heparin or a direct Factor Xa inhibitor is preferred
- •14. Active bleeding or pathologic condition that carries a high risk of bleeding (e.g., hereditary hemorrhagic telangiectasia). Patients with bleeding cutaneous lesions not actively requiring transfusions are eligible. Patients who have been uneventfully anti-coagulated with a direct Factor Xa inhibitor or low
- •molecular weight heparin are eligible
- •15. Hemoptysis (> ½ teaspoon [2.5 mL] of bright red blood) within 6 months prior to randomization
- •16. Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to randomization
- •17. Known active viral or nonviral hepatitis or cirrhosis
- •18. Peptic ulcer within the past 3 months prior to randomization, unless treated for the condition and complete resolution has
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