EUCTR2011-003407-38-GB进行中（未招募）1 期
A Phase I Study of Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Treatment in Paediatric Patients with Advanced Solid Tumours - Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- •Male or female age 6 to 17 years (included) on day of signing informed consent are eligible for Parts 1-3 of this study. Additionally, children ages 3 to 5 years are eligible for treatment in the dalotuzumab monotherapy dose escalation cohort (Part 1). • Histologic or cytologic diagnosis of a malignant solid tumour, including tumours of the central nervous system and lymphoma that have progressed despite standard therapy or for which no effective standard therapy is known. • Patients may have measurable (per RECIST 1.1) or non-measurable disease for Parts 1 and 2. Patients enrolled in Part 3 must have measureable disease. • Patient must be able to swallow tablets. (Patients to be enrolled into Parts 2 & 3). • Performance Status: Lansky Play Scale =70 for children <10 years of age; Karnofsky score =70 for children =10 to <16 years; or ECOG Status 0-2 for patients age 16 and older. • Adequate organ functions. • Patient has a Body Surface Area (BSA) that allows evaluation of the current dose level. (For Ridaforolimus-containing Parts 2 and 3 only). • For females of reproductive potential, a negative pregnancy test must be documented within 72 hours of receiving the first dose of study medication. • A patient who is of reproductive potential agrees to use (or have their partner use). two adequate barrier methods of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with Visit 1 through 30 days after the last dose of study drug. Approved contraceptive methods include for example: intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients currently receiving any other investigational agents or using any investigational devices. • Patients with leukaemia. • Patients who have previously received dalotuzumab or other IGF-1R inhibitors (Part 1). • History of allergic reactions attributed to compounds of similar chemical or biologic composition to dalotuzumab (Patients to be enrolled into Parts 1-3) or ridaforolimus (Patients to be enrolled into Parts 2-3). • Patient has persistent acute toxicity from previous therapy = Grade 2 by NCI CTCAE Version 4 (excluding alopecia, neuropathy, or hearing loss). • Uncontrolled intercurrent illness. • Pregnancy or females who are breastfeeding. • Patients to be enrolled into Parts 2-3 only: Patient has a requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A). Patients should be off these medications for at least 2 weeks prior to the first dose of ridaforolimus. • Patient who has received an allogeneic stem cell transplant. The use of autologous stem cell rescue for high-dose chemotherapy is allowed any time prior to enrollment as long as patients meet baseline hematologic criteria. • Patient has poorly controlled Type 1 or 2 diabetes, defined as a fasting glucose >160 mg/dL.
研究者
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