Investigator-initiated clinical trial of DS-3032b in patients with MDM2 amplified intimal sarcoma (MADAME PRINCESA)

National Cancer Center Hospital0 个研究点开始时间: 待定最近更新: 2024年6月7日

试验速览

暂无简介。

•1.Has a histologically or cytologically documented intimal sarcoma
•2.Has a tumor harboring an amplified MDM2 determined previously or at screening by IHC, FISH or NGS
•3.Refractory to conventional chemotherapy or unresectable setting, or for which no standard treatment is available
•4.Performance Status (ECOG) 0 - 2
•5.Enrolled in MASTER KEY Registry study
•6.Has measurable disease as per RECIST v1.1
•7.Has adequate bone marrow function, renal function and hepatic function, defined as:
•Absolute neutrophil count 1500 / mm3
•Hemoglobin 8.0 g/dL
•Platelet count 100000/ mm3
•AST≦100 U/L(if liver metastases are present, 150U/L)
•ALT 100 U/L(if liver metastases are present, 150U/L)
•Bilirubin 2.0mg/dL
•Creatinine clearance 45 mL/min or creatinine 1.5 mg/dL
•8.Provides written informed consent
•9.Had treatment free time, defined as
•Systemic anticancer therapy, including antibody-based therapy, within 3 weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment
•Hormonal therapy within 3 weeks before study drug treatment
•Radiation therapy or major surgery within 3 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment
•Major surgery within 3 weeks before study drug treatment or minor surgery within 2 weeks before study drug

•1.Has a concomitant medical condition , defined as below,
•Acute myocardial infarction, unstable angina, arrhythmia requiring treatment, coronary artery or peripheral artery bypass, active or uncontrolled thromboembolism, autoimmune disease requiring systemic treatment, uncontrolled infection requiring systemic treatment (intravenous antibiotics, antivirals, or antifungals) or active gastrointestinal ulcer
•2.Has medical history, complication or imaging sign of clinically significant lung disease such as intestinal lung disease, pneumonitis, lung fibrosis, severe radiation pneumonitis
•3.Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
•4.Has known human immunodeficiency virus infection, active hepatitis B defined as HBs antigen or positive HBV-DNA , or C infection define as anti-HCV antibody
•5.Though HBs antigen-negative, HBs antibody-positive and/or HBc antibody-positive, and HBV-DNA quantitative test positive
•6.Women of child-bearing potential. Women lactating (nursing) or within 28 days after delivery
•7.Given no consent to contraception while taking study drug and for 6 months after study drug discontinuation
•8.Has concurrent malignancy

Number of patients with objective response (central review)

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