EUCTR2011-003145-17-IT进行中（未招募）1 期
A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 640
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. Male or female = 15 years of age 2. Ability to understand the purposes and risks of the study and has signed or, if appropriate, the subject's parent or legal guardian has signed a written informed consent form approved by the investigator's IRB/Ethics Committee 3. Pathologically confirmed diagnosis of soft tissue sarcoma of the following histopathologic types: ? Synovial sarcoma ? High grade fibrosarcoma ? Undifferentiated sarcoma; sarcoma not otherwise specified (NOS) ? Liposarcoma ? Leiomyosarcoma (excluding GIST) ? Angiosarcoma (excluding Kaposi's sarcoma) ? Malignant peripheral nerve sheath tumor ? Pleomorphic Rhabdomyosarcoma ? Myxofibrosarcoma ? Epithelioid sarcoma ? Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (MFH) (including pleomorphic, giant cell, myxoid and inflammatory forms) 4. Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate 5. Recovered from reversible toxicities of prior therapy 6. Measurable disease by RECIST 1.1 criteria (at least one target lesion outside of previous radiation fields or progressed within a previous radiation field) 7. ECOG performance status of 0 or 1 8. Life expectancy of at least 3 months 9. Acceptable liver function: ? Bilirubin = 1.5 x upper limit of normal (ULN) ? AST (SGOT) and ALT (SGPT) = 3.0 x ULN); if liver metastases are present, then = 5 x ULN is allowed 10. Acceptable renal function: ? Serum creatinine = 1.5 times ULN or calculated creatinine clearance = 60 mL/min 11. Acceptable hematologic status (without hematologic support): ? ANC = 1500 cells/µL ? Platelet count = 100,000/µL ? Hemoglobin = 9.0 g/dL 12. Acceptable cardiac function: ? Normal 12-lead ECG (clinically insignificant abnormalities permitted) ? LVEF normal by MUGA or echocardiogram 13. All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose. Post-menopausal women must meet the criteria of 12 months of natural(spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >35 mIU/ml (IU/L).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 335
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Prior systemic therapy for advanced or metastatic disease (neoadjuvant therapy followed by surgical resection and adjuvant therapy permitted) 2. Low grade tumors according to standard grading systems (eg AJCC Grade 1 and 2 or FNCLCC Grade 1) 3. Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards 4. Prior therapy with an anthracycline or anthracenedione5. Prior mediastinal/cardiac radiotherapy 6. Current use of drugs with known cardiotoxicity or known interactions with doxorubicin 7. Anti-cancer treatment with radiation therapy, neoadjuvant or adjuvant chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), immunotherapy, hormones or other antitumor therapies within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C) 8. Significant cardiac dysfunction precluding treatment with doxorubicin: ? Any history of congestive heart failure ? Myocardial infarction within the past 6 months or severe myocardial insufficiency ? Uncontrolled arrhythmias within the past 6 months ? Angina pectoris requiring antianginal medication within the past 6 months ? Clinically significant valvular heart disease ? Poorly controlled hypertension within the last 6 months 9. Seizure disorders requiring anticonvulsant therapy unless seizure-free for the last year 10. Known brain metastases (unless previously treated and well controlled for a period of = 3 months) 11. Previously treated malignancies, except for adequately treated nonmelanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years 12. Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia 13. Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery 14. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy 15. Prior therapy with a hypoxic cytotoxin 16. Subjects who participated in an investigational drug or device study within 28 days prior to study entry 17. Known infection with HIV, hepatitis B, or hepatitis C 18. Subjects who have exhibited allergic reactions to a structural compoundsimilar to TH-302, doxorubicin or their excipients 19. Females who are pregnant or breast-feeding 20. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study 21. Unwillingness or inability to comply with the study protocol for any reason
研究者
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Study investigating a new medicine- TH-302- in patients diagnosed with Locally advanced soft tissue sarcoma that is not resectable or is diseminated. Study has two groups: One group of patients will betreated with TH-302 in Combination with Doxorubicin and a second one with Doxorubicin Alone. Both the patient and the doctor will know the treatment group.ocally Advanced Unresectable or Metastatic Soft Tissue SarcomaMedDRA version: 15.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003145-17-DKThreshold Pharmaceuticals, Inc.620
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Study investigating a new medicine- TH-302- in patients diagnosed with Locally advanced soft tissue sarcoma that is not resectable or is diseminated. Study has two groups: One group of patients will betreated with TH-302 in Combination with Doxorubicin and a second one with Doxorubicin Alone. Both the patient and the doctor will know the treatment group.EUCTR2011-003145-17-DEThreshold Pharmaceuticals, Inc.620