EUCTR2008-005806-38-FR进行中（未招募）1 期
A multiple ascending dose study to evaluate the safety, tolerability and effect on tumor response of the mTOR inhibitor (RAD001) in combination with the IGF-1R antagonist (R1507) in patients with advanced solid tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 134
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. [Phase Ib] Patients must have histologically confirmed recurrent or refractory advanced solid malignancy with no known standard of care according to the judgment of the investigator (including Hodgkin’s and non-Hodgkin’s lymphoma)
- •[Phase II] Patients must have histologically confirmed:
- •Advanced metastatic renal cell carcinoma (RCC) with evidence of progressive disease despite prior VEGFr- TKI therapy.
- •Advanced low- to intermediate grade metastatic or unresectable locoregional pancreatic neuroendocrine tumors (pNET) and carcinoid tumors who have failed standard therapy and have evidence of progressive disease. Patients with either carcinoid or islet cell tumors
- •will be included in this cohort.
- •2. Measurable disease according to RECIST in Phase II
- •3. Male and female patients, = 18 years age
- •5. Patients with treated, asymptomatic, stable CNS metastases are eligible for enrollment only if:
- •Patient has received prior treatment to the site(s) of CNS metastatic disease at least 4 weeks prior to treatment
- •Patient has no requirement for glucocorticoids (discontinued at least 3 weeks prior to treatment)
- •Patient is not taking anticonvulsants (discontinued at least 3 weeks prior to treatment)
- •Patient has no overt evidence of neurological deficit
- •6. ECOG performance status 0-2
- •7. Patients must have adequate organ and marrow function
- •8. Negative pregnancy test (serum ß-HCG) within 7 days of startingStudy treatment in women of childbearing potential (both premenopausal women and women < 2 years after the onset of menopause).
- •10. HbA1c = 7% at screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior treatment with agents that act via inhibition of the IGF-1R
- •2. Prior treatment with agents that act via mTOR inhibition (e.g. sirolimus, temsirolimus, everolimus) for the phase II portion only.
- •3. Patients with untreated CNS metastases.
- •5. Previous or current anti cancer therapy: Patients who are currently receiving any anti cancer therapy (other than those administered on this study) or who have received:
- •Radiotherapy = 4 weeks prior to enrollment
- •Chemotherapy (including biologic therapy) = 4 weeks prior to enrollment
- •Patients who have received therapy more than 4 weeks prior to enrollment who have not recovered adverse events to = grade 1, (excluding alopecia)
- •7. History of allogeneic bone marrow transplantation or organ transplantation.
- •11. Patients who are pregnant or breastfeeding.
- •12. Fertile men and women of childbearing potential not employing an effective method of birth control throughout the trial and for 3 months after last study drug administration in both sexes. Women of childbearing potential must have a negative pregnancy test (serum ß- HCG) within the 7 days prior to study drug administration.
- •13. Known hypersensitivity to R1507 or its excipients or to RAD001 or compounds of similar chemical or biologic composition to RAD001.
- •14. Any known severe and/or uncontrolled medical conditions
研究者
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