NL-OMON39691已完成2 期
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel with MORAb-004 in Metastatic Soft Tissue Sarcoma - MORAb-004 in Metastatic Soft Tissue Sarcoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Be at least 18 years of age
- •2. Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period
- •3. Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study subgroups
- •4. Have been treated in the metastatic setting with 0 to 2 prior systemic regimens for mSTS systemic treatment regimens given in the neoadjuvant or adjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for purposes of this protocol. Prior treatment with an anthracycline-based regimen is allowable but not required. (Subjects with extraskeletal small round blue cell sarcomas must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy.) Subjects with rhabdomyosarcomas must have exhausted or be intolerant of standard first-line therapy; anthracycline therapy for rhabdomyosarcoma is allowable but not required.
- •5. Have measurable disease, as defined by RECIST v.1.1, assessed within 30 days prior to the first dose of study drug. Subjects who are receiving second- or third-line therapy must have radiologically documented disease progression (per RECIST v1.1) present within 6 months prior
- •to randomization. For subjects who are receiving first-line therapy, no documentation of progression is required.
- •6. Have an interval between prior cancer treatment and first infusion of test article (MORAb-004 or placebo) of at least 2 weeks (If the immediately prior regimen of cancer treatment included an antibody, a therapeutic protein, or an investigational agent, the minimum interval between prior treatment and first infusion of study drug is 4 weeks.)
- •7. Have all toxicity of immediately prior treatments, except alopecia, controlled to a severity of less than or equal to Grade 1 (mild)
- •8. Have laboratory test results within the 2 weeks prior to Study Day 1 as indicated below
- •* Absolute neutrophil count at least 1.0 × 109/L
- •* Platelet count at least 100 × 109/L
- •* Hemoglobin at least 8 g/dL
- •* Creatinine no greater than 1.5 × upper limit of normal (ULN) (National Cancer Institute Common
- •Terminology Criteria for Adverse Events [NCI CTCAE] Grade 1)
- •* Bilirubin less than ULN (NCI CTCAE Grade 1), with the exception of subjects with Gilbert's
- •disease. This inclusion criterion will be waived for subjects with Gilbert's disease
- •* Aspartate aminotransferase and alkaline phosphatase less than 2.5 × ULN (NCI CTCAE Grade 1) (Additionally if ALT or AST >1.5 x ULN, alkaline phosphatase must be < 2.5 x ULN)
- •* Activated partial thromboplastin time (aPTT) and prothrombin time (PT) less than 1.5 × ULN (NCI CTCAE Grade 1)(For subjects who are receiving anticoagulation, the aPTT and INR must be stable and considered baseline for the subject.) (see Section 5.7.2 for management of subjects receiving anticoagulation.)
- •9. Have a life expectancy of at least 3 months, as estimated by the investigator.
- •10. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •11. Have tumor tissue available for biomarker studies
- •12. Have any other significant medical conditions well controlled and stable, in the opinion of the investigator, for at least 30 days prior to Study Day 1.
- •13. Be willing and able to provide written informed consent.
排除标准
- •1. Have received more than 2 prior systemic treatment regimens for mSTS
- •2. Have received either gemcitabine or docetaxel in any previous treatment for STS (regardless of the line of treatment).
- •3. Have a diagnosis of primary bone sarcoma of any histologic type.
- •4. Have evidence of active malignancy, other than mSTS, that required systemic or local treatment within the past 2 years (except basal cell or squamous cell skin cancer).
- •5. Have any other serious systemic disease, including active bacterial or fungal infection, or any medical condition requiring current cytotoxic therapy or current chronic (more than 4 consecutive weeks) systemic corticosteroid treatment
- •6. Have a history of clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4, angina not well-controlled by medication, or myocardial infarction within the past 6 months), a history of abnormal ejection fraction within the past 6 months, using institutional limits of normal), or clinically significant arrhythmia on electrocardiograph (ECG) within the past 6 months
- •7. Have a medical condition with a high risk of bleeding or have a recent (within past 6 months) history of a significant bleeding event.
- •8. Have undergone major surgical procedures or open biopsy, have significant traumatic injury within 30 days prior to the first date of study treatment or have major dsurgical procedures anticipated during the study.
- •9. Have active viral hepatitis or symptomatic HIV infection (Asymptomatic positive serology is acceptable)
- •10. Have a current serious non-healing would, and ulcer or bone fracture.
- •11. Have a history of allergic reaction to prior monoclonal antibody or biologic agent
- •12. Have received previous treatment with MORAb-004 (anti-TEM-1)
- •13. Be currently breastfeeding, pregnant, or likely to become pregnant during the study
- •14. Have known central nervous system tumor involvement or metastases
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