NCT00319748已完成2 期
Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
研究概览
简要总结
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment.
详细描述
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate performance status:
- •Breast - Karnofsky score > 50;
- •Ovarian, endometrial or cervical - Gynecologic Oncology Group (GOG) performance score ≤2
- •If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation.
- •Normal organ function within 14 days of study entry
- •Diagnosis of one of the following malignancies:
- •Metastatic breast cancer (BR)
- •Metastatic ovarian cancer (OV)
- •Metastatic endometrial cancer (EM)
- •Metastatic cervical cancer (CX)
- •Breast Cancer Inclusion Criteria:
- •Measurable metastatic disease (>1cm) in at least one site other than bone-only
- •Progression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease
- •Progression on prior therapy with a hormonal agent if estrogen receptor or progesterone receptor positive, and/or with trastuzumab if HER2-neu positive. If patient has progressed through hormone or trastuzumab therapy only, must have received one chemotherapy regimen.
- •Ovarian Cancer Inclusion Criteria:
- •Measurable metastatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- •Primary tumor must have been diagnosed histologically as either epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (not borderline or low malignant potential epithelial carcinoma).
- •Subjects must have failed at least two previous chemotherapy regimens. Paclitaxel must have been a component of one or both regimens and cisplatin or carboplatin must have been a component of one or both regimens.
- •Endometrial Cancer Inclusion Criteria:
- •Measurable metastatic disease
- •Histologically proven recurrent or persistent endometrial cancer that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens
- •Cervical Cancer Inclusion Criteria:
- •Measurable metastatic disease
- •Histologically proven recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens.
排除标准
- •Had/have the following prior/concurrent therapy:
- •Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)
- •Investigational drugs/agents within 14 days of first dose of 852A
- •Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)
- •Drugs known to induce QT interval prolongation and/or induce Torsades de pointes unless best available drug required to treat life-threatening conditions
- •Radiotherapy within 3 weeks of the first dose of 852A
- •Hematopoietic cell transplantation within 4 weeks of first dose of 852A
- •Evidence of active infection within 3 days of first dose of 852A
- •Active fungal infection or pulmonary infiltrates (prior treated disease stable for 2 weeks is allowable)
- •Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
- •History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
- •Uncontrolled intercurrent or chronic illness
- •Active autoimmune disease requiring immunosuppressive therapy within 30 days
- •Active coagulation disorder not controlled with medication
- •Pregnant or lactating
- •Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas that have been adequately treated
- •Any history of brain metastases or any other active central nervous system (CNS) disease
研究组 & 干预措施
Intent-To-Treat
Experimental
Patients treated with at least one dose - 852A subcutaneous injection.
干预措施: 852A (Drug)
Evaluable Cohort
Experimental
Patients who received all 24 doses of 852A per protocol.
干预措施: 852A (Drug)
结局指标
主要结局
Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
时间窗: after 12 weeks (24 doses of 852A)
Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.
次要结局
- Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)(Prior to Dose 1 and 6 hours after Dose 1)
- Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)(Prior to Dose 1 and 6 Hours Post-Dose)
- Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)(Prior to Dose 1 and 6 Hours Post-Dose)
- Mean Difference Values for Soluble CD40 Ligand (sCD40L)(Prior to Dose 1 and 6 Hours Post-Dose)
- Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)(Prior to Dose 1 and 6 Hours Post-Dose)
- Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)(Prior to Dose 1 and 6 Hours Post-Dose)
研究者
研究点 (1)
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