NL-OMON47908已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with Advanced or Metastatic Soft Tissue Sarcoma - I5B-MC-JGDJ (ANNOUNCE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eli Lilly
- 入组人数
- 16
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
- •Patients are eligible to be included in the study only if they meet all of the following criteria:
- •[1] The patient signed an ICF and authorization for release of health information for
- •research prior to any study-specific procedures being performed.
- •[2] The patient is aged >= 18 years at study entry.
- •[3] The patient has histologically confirmed diagnosis of locally advanced unresectable or
- •metastatic STS not amenable to curative treatment with surgery or radiotherapy.
- •Patients with a diagnosis of Grade 1 liposarcoma are eligible if there is histological or
- •radiographic evidence of evolution to more aggressive disease. Patients with Kaposi*s
- •sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Note: Evidence of disease progression is required for patients that are not newly diagnosed.
- •[4] The patient has measurable or nonmeasurable but evaluable disease as defined by the
- •Response Evaluation Criteria in Solid Tumors (RECIST 1.1, Eisenhauer et al. 2009;
- •refer to Attachment 6 of the Protocol). Tumors within a previously irradiated field will be designated
- •as *nontarget* lesions unless progression is documented or a biopsy is obtained to
- •confirm persistence at least 90 days following completion of radiotherapy.
- •[5] The patient has a performance status 0-1 on the Eastern Cooperative Oncology Group
- •(ECOG) scale (refer to Attachment 4 of the Protocol).
- •[6] The patient has not received any previous treatment with anthracyclines.
- •[7] The patient may have had any number of prior systemic cytotoxic therapies for
- •advanced/metastatic disease and are considered appropriate candidates for
- •anthracycline therapy. All previous anticancer treatments must be completed >= 3 weeks
- •(21 days) prior to first dose of study drug.
- •[8] The patient has resolution of adverse events and of all clinically significant toxic effects
- •of prior locoregional therapy, surgery, radiotherapy, or systemic anticancer therapy to
- •<= Grade 1, by National Cancer Institute - Common Terminology Criteria for Adverse
- •Events (NCI-CTCAE) Version 4.0.
- •[9] Availability of tumor tissue is mandatory for study eligibility. The patient must have
- •consented to provide archived formalin-fixed paraffin embedded (FFPE) tumor tissue
- •or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for
- •future central pathology review and translational research (if archived tissue is
- •unavailable) (refer to Section 10.4.2.3 of the Protocol regarding tissue collection parameters).
- •[10] The patient has adequate hematologic, organ, and coagulation function within 2 weeks
- •(14 days) prior to randomization:
- •Absolute neutrophil count (ANC) >=1.5 x 109/L. Granulocyte colony-stimulating
- •factor (G-CSF) cannot be administered within 2 weeks (14 days) prior to
- •randomization.
- •Platelet count >=100 x 109/L
- •Hemoglobin >=9.0 g/dL. No transfusions are allowed within 2 weeks (14 days) prior to randomization.
- •The creatinine clearance is >=45 mL/min (refer to Attachment 5 for the Cockcroft-Gault formula)
- •Proteinuria <=1000 mg in 24 hours (if routine urinalysis indicates >=2+ proteinuria)
- •Total bilirubin below upper limit of normal (ULN) (except for patients with Gilbert*s Syndrome, who must have a total bilirubin <3 mg/dL)
- •Alanine aminotransferase/aspartate aminotransferase (AST/ALT) <= 3.0 × ULN; if the liver has tumor inv
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •[15] The patient is diagnosed with GIST or Kaposi sarcoma.
- •[16] The patient has active central nervous system (CNS) or leptomeningeal metastasis
- •(brain metastasis) at the time of randomization. Patients with a history of a CNS
- •metastasis previously treated with curative intent (for example, stereotactic radiation or
- •surgery) that have not progressed on follow-up imaging, have been asymptomatic for at
- •least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are
- •eligible. Patients with signs or symptoms of neurological compromise should have
- •appropriate radiographic imaging performed before randomization to rule out brain
- •metastasis.
- •[17] The patient has received prior treatment with doxorubicin, epirubicin, idarubicin, and/or
- •other anthracyclines or anthracenediones; the patient has received prior treatment with olaratumab or has participated in a prior olaratumab trial.
- •[18] The patient had prior radiotherapy of the mediastinal/pericardial area or whole pelvis
- •[19] The patient has history of another primary cancer, with the exception of a) curatively
- •treated non-melanomatous skin cancer, b) curatively treated cervical carcinoma in situ,
- •c) other primary non-hematologic malignancies or solid tumor treated with curative
- •intent, no known active disease and no treatment administered during the last 3 years
- •prior to randomization.
- •[20] The patient has electively planned or will require major surgery during the course of the
- •[21] The patient has uncontrolled intercurrent illness including, but not limited to, an
- •ongoing/active infection requiring parenteral antibiotics, symptomatic congestive heart
- •failure (CHF), left ventricular dysfunction (LVEF < 50%), severe myocardial
- •insufficiency, cardiac arrhythmia, cardiomyopathy, or a psychiatric illness/social
- •situation that would limit compliance with study requirements.
- •[22] The patient has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial
- •infarction within 6 months of randomization.
- •[23] DELETED
- •[24] The patient has a QTcB interval of >450 msec for males and >470 msec for females on
- •screening electrocardiogram (ECG) utilizing Bazett*s correction (refer to formula in
- •Table JGDJ.8 of the Protocol).
- •[25] Females who are pregnant or breastfeeding
- •[26] The patient has a known allergy to any of the treatment components including a history
- •of allergic reactions attributed to compounds of chemical or biological composition
- •similar to olaratumab.
- •[27] The patient is enrolled in, or discontinued study treatment from another trial involving
- •an investigational agent or use of non-approved drug or device within 28 days of being
- •randomized in this trial, or concurrent enrollment in any other type of medical research
- •judged scientifically or medically incompatible with this trial. Patients participating in
- •surveys or observational studies are eligible to participate in this study.
- •[28] DELETED.
- •[29] The patient has a known investigator-assessed active fungal, bacterial, or viral infection including
- •human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not
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