EUCTR2015-003594-14-ES进行中（未招募）1 期
A Phase 2-3 Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) versus Placebo in Patients with Advanced Unresectable Dedifferentiated Liposarcoma (DDLS) - SEAL: Selinexor in Advanced Liposarcoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 342
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
- •Patients eligible for inclusion in this study must meet all of the following criteria:
- •1. Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any screening procedures
- •2. Must be willing and able to comply with the protocol
- •3. Patients = 12 years of age
- •4. Patients with a BSA = 1.2 m2 as calculated per Dubois 1916 or Mosteller 1987
- •5. Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment:
- •This information will be provided based on prior diagnostic testing and is required for randomization.
- •Tissue (fresh or archival) will be provided for confirmatory histology at a central laboratory but confirmatory results are not required prior to randomization.
- •If archival tissue > 12 months old, the quality of the sample for confirmatory histology must be confirmed by the site histopathologist prior to randomization.
- •6. Must have measurable disease according to:
- •The bidimensional WHO Response Criteria (Miller 1981) (Phase 2 patients only)
- •RECIST v. 1.1 (Eisenhauer 2009)(Phase 3 patients only)
- •7. Radiologic evidence of progressive disease (PD) within 6 months prior to randomization. If the patient received other intervening therapy after PD is documented, further PD must be documented after the completion of the intervening therapy.
- •8. Must have received at least 2 but no more than 5 prior systemic therapies for the treatment of liposarcoma.
- •9. Patients should have recovered from all major surgery, radiation or other interventions = 21 days prior to randomization. Patients must have recovered from any clinically significant therapy-related toxicity to = Grade 1 per CTCAE v. 4.03. Minor procedures, such as biopsies, dental work, or placement of a port or intravenous line for infusion, are permitted.
- •10. If patients received any previous systemic therapy, the last dose must have been = 21 days prior to randomization (or = 5 half-lives of that drug [whichever is shorter]), with all clinically significant therapy-related toxicities having resolved to = Grade 1 CTCAE v. 4.03.
- •11. ECOG performance status = 1 (Oken 1982)
- •12. Adequate laboratory functional values:
- •Adequate hematopoietic function:
- •o Absolute neutrophil count (ANC) = 1500/mm3
- •o Platelets = 100,000/mm3
- •o Hemoglobin (Hb) = 9 g/dL at baseline
- •o Transfusions, hematopoietic growth factors, and hematinics are NOT permitted during screening
- •Adequate hepatic function:
- •o Bilirubin = 1.5 x upper limit of normal (ULN) (except patients with Gilbert’s syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of = 3 x ULN)
- •o Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) < 3.0 x ULN (except patients with liver involvement of their liposarcoma who must have an AST and ALT = 5 x ULN).
- •Adequate renal function: estimated creatinine clearance of = 50 mL/min, calculated using the Cockcroft and Gault formula (140 – Age) • Mass (kg)/ (72 • creatinine mg/dL); multiply by 0.85 if female (Cockcroft 1976).
- •13. Female patients of childbearing potential must agree to use two methods of contraception (including one highly effective and one effective method of contraception [as defined in Section 12.2.5.3]) and have a negative serum pregnancy test at Screening. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female
排除标准
- •Patients meeting any of the following exclusion criteria are not eligible to enroll in this study:
- •1. Patients with liposarcoma of pure WDLS, myxoid/round cell or pleomorphic tumor histologic subtypes.
- •2. Significant cardiovascular impairment, defined as:
- •a. Cardiac failure, New York Heart Association (NYHA) Class = 3 according to the NYHA Functional Classification
- •b. Unstable angina or myocardial infarction within 3 months of enrollment
- •c. Serious and potentially life-threatening arrhythmia.
- •3. Patients with known central nervous system metastases.
- •4. Female patients who are pregnant or nursing.
- •5. Prior malignancy that required treatment, or has shown evidence of recurrence (except for non melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 5 years prior to randomization. Cancer treated with curative intent > 5 years prior to randomization and without evidence of recurrence is allowed.
- •6. Known active Hepatitis B (HepB), Hepatitis C (HepC) or human immunodeficiency virus (HIV) infection. Note: (HepB, HepC, or HIV testing is not required as part of this study).
- •7. Any medical condition, such as an uncontrolled infection or uncontrolled diabetes mellitus (Type 2), which in the opinion of the Investigator would make study involvement unreasonably hazardous
- •8. Psychiatric illness that would prevent the patient from giving informed consent or being compliant with the study procedures
- •9. Patients unable to swallow tablets, patients with malabsorption syndrome, or any other GI disease or GI dysfunction that could interfere with absorption of study treatment
- •10. Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia/cachexia (palliative care).
- •11. Patients who had involuntary weight loss of = 10% in the 3 months prior to randomization.
- •12. Participation in an investigational anticancer study = 21 days prior to randomization.
研究者
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