NCT02255110终止2 期
A Phase II, Single-arm, Japanese Multicenter Trial of TH-302 in Combination With Doxorubicin in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) by Independent Central Review (Phase II Treatment Period)
研究概览
简要总结
This is a Phase 2, single-arm, Japanese multicenter trial to evaluate the safety, tolerability, and efficacy of TH-302 in combination with doxorubicin in subjects with locally advanced unresectable or metastatic soft tissue sarcoma (STS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Japanese subjects greater than or equal to (>=) 15 years of age
- •Able to understand the purposes and risks of the trial and has signed or, if appropriate, the subject's parent or legal guardian has signed a written informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
- •Pathologically confirmed diagnosis of STS of the histopathologic types as specified in the protocol
- •Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate
- •Recovered from reversible toxicities of prior therapy
- •Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (at least one target lesion outside of previous radiation fields or progressed within a previous radiation field)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy of at least 3 months
- •Acceptable liver function, renal function, hematologic status (without growth factor support for neutropenia or transfusion dependency), and cardiac function as specified in the protocol
- •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 intrauterine device, intrauterine device [IUD]) with their partner from entry into the trial 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 follicle-stimulating hormone (FSH) levels greater than (>) 35 international units per liter (IU/L)
排除标准
- •Low grade tumors according to standard grading systems (for example, American Joint Committee on Cancer [AJCC] Grade 1 and 2 or Fédération Nationale des Centres de Lutte Contre le Cancer [FNCLCC] Grade 1)
- •Prior systemic therapy for advanced or metastatic STS (neoadjuvant therapy followed by surgical resection and adjuvant therapy permitted)
- •Prior STS therapy with ifosfamide or cyclophosphamide or other nitrogen mustards; prior systemic therapy with an anthracycline or anthracenedione; or prior mediastinal/cardiac radiotherapy
- •Current use of drugs with known cardiotoxicity or known interactions with doxorubicin
- •Anti-cancer treatment with radiation therapy, neoadjuvant or adjuvant chemotherapy, targeted therapies, immunotherapy, hormones or other antitumor therapies within 4 weeks prior to trial entry (6 weeks for nitrosoureas or mitomycin C).
- •Significant cardiac dysfunction precluding treatment with doxorubicin as specified in the protocol
- •Seizure disorders requiring anticonvulsant therapy unless seizure-free for the last year
- •Known brain metastases (unless previously treated and well controlled for a period of >=3 months before screening)
- •Previously diagnosed malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years before screening
- •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
- •Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- •Prior therapy with a hypoxic cytotoxin
- •Subjects who participated in an investigational drug or device trial within 28 days prior to trial entry
- •Known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B or hepatitis C
- •Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or the drug product excipients
- •Subjects who are taking medications that prolong QT interval and have a risk of Torsades de Pointes
- •Subjects with a corrected QT (QTc) interval calculated according to Bazett's formula of >450 milliseconds (msec) based on a screening electrocardiogram (ECG)
- •Subjects with a history of long QT syndrome
- •Subjects taking a medication that is a moderate or strong inhibitor or inducer of cytochrome P450 3A4 (CYP3A4)
- •Females who are pregnant or breast-feeding
- •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
- •Unwillingness or inability to comply with the study protocol for any reason
- •Legal incapacity or limited legal capacity
研究组 & 干预措施
TH-302 and doxorubicin
Experimental
干预措施: Doxorubicin (Drug)
TH-302 and doxorubicin
Experimental
干预措施: TH-302 (Drug)
结局指标
主要结局
Progression Free Survival (PFS) by Independent Central Review (Phase II Treatment Period)
时间窗: From first dose of study drug administration until PD or death, evaluated at 6 months
PFS was planned to assess as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive Disease is defined as at least a 20 percent (%) increase in the Sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
次要结局
- Progression-free Survival (PFS) by Investigator and Independent Central Review (Phase II Treatment Period)(From first dose of study drug administration until PD or death, evaluated at 3 months and 9 months)
- Best Overall Response (BOR) by Independent Central Review (Phase II Treatment Period)(From first dose of study drug administration until PD or death, assessed up to 12 months)
- Progression Free Survival (PFS) by Investigator Review (Phase II Treatment Period)(From first dose of study drug administration until PD or death, evaluated at 6 months)
- Progression-free Survival (PFS) (Phase II Treatment Period)(From first dose of study drug administration until PD or death, assessed up to 12 months)
- Duration of Response (Phase II Treatment Period)(From first dose of study drug administration until PD or death, assessed up to 12 months)
- Best Overall Response (BOR) by Investigator (Phase II Treatment Period)(From first dose of study drug administration until PD or death, assessed up to 12 months)
- Overall Survival (OS) (Phase II Treatment Period)(From first dose of study drug administration until the last subject completes the survival follow-up, assessed up to 12 months)
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (Safety Run-In Phase)(From baseline until end of trial, assessed up to Day 210)
研究者
研究点 (1)
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