EUCTR2012-001399-12-NL进行中（未招募）1 期
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel with MORAb-004 in Metastatic Soft Tissue Sarcoma - MORAb-004-203 Soft Tissue Sarcoma Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. 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 received 0 to 2 prior regimens of systemic treatment 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. [French subjects only: Subjects will only be enrolled in the first line setting if (1) there is a contraindication to anthracycline treatment or (2) they have received anthracycline as adjuvant or neoadjuvant treatment.]
- •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 (except alopecia) of most recent treatments
- •controlled to a severity of less than or equal to a Grade 1 (mild) prior to
- •administration of test article
- •8. Have laboratory test results within the 2 weeks prior to Study Day 1
- •as indicated below
- •– Absolute neutrophil count at least 1.5 × 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, with the exception of subjects with Gilbert's disease. This inclusion criterion will be waived for subjects with Gilbert's disease
- •– Aspartate aminotransferase (AST) and alanine aminotransferase
- •(ALT), less than 2.5 × ULN (NCI CTCAE Grade 1) (Additionally, if ALT
- •and/or AST >1.5 × ULN, alkaline phosphatase must be <2.5 × ULN. No
- •adjustments to these criteria are made for subjects with hepatic
- •metastases.)
- •– 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.)
- •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 (Tumor tissue
- •from the original diagnostic biopsy is required. Tumor tissue from an
- •optional biopsy of an accessible lesion at Screening may b
排除标准
- •1. Have received more than 2 prior systemic treatment regimens for
- •2. Have received either gemcitabine or docetaxel in 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), any medical condition requiring current cytotoxic
- •therapy, or current use of daily 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 wellcontrolled by medication, or myocardial infarction within 6 months), a
- •history of abnormal ejection fraction within the past 6 months (using
- •institutional limits of normal), or a clinically significant arrhythmia on
- •electrocardiograph (ECG) within the past 6 months
- •7. Have a medical condition with a high risk of bleeding, (e.g., a known
- •bleeding disorder, a coagulopathy, or a tumor that involves the major
- •vessels) 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 surgical procedures anticipated during the
- •9. Have active viral hepatitis or symptomatic HIV infection
- •(Asymptomatic positive serology is not exclusionary.)
- •10. Have a current serious nonhealing wound, an ulcer (including
- •gastrointestinal), or a 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
研究者
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