EUCTR2009-009461-33-IT进行中（未招募）不适用
A Phase IIa, Open-Label, Dose-Escalating Study to Evaluate the Safety of AV-951 in Combination with Everolimus in Subjects with Metastatic Renal Cell Carcinoma - ND
AISAR ASSOCIAZIONE ITALIANA PER LO STUDIO DEGLI ANTIMICROBICI E DELLE RESISTENZE0 个研究点开始时间: 2009年4月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.≥ 18-year-old males or females
- •2.Histologically confirmed renal cell carcinoma.
- •3.Documented metastatic disease
- •4.Clinical and laboratory data that at discretion of the investigator allow to perform contrast enhancement CT scan
- •5.Measurable disease by RECIST criteria (see Appendix A)
- •6.No more than 1 prior VEGF receptor targeted therapy; no prior treatment with everolimus (RAD-001; Certican) or other drugs targeting the mTOR pathway
- •7.ECOG performance < 2 and life expectancy ≥ 6 months (see Appendix B)
- •8.Signed and dated informed consent
- •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.Primary CNS malignancies; active CNS metastases
- •2.Hematologic malignancies (including leukemia in any form, lymphoma, and multiple myeloma)
- •3.Any of the following hematologic abnormalities:Hemoglobin < 8.5 g/dL,ANC < 1500 per mm3,Platelet count < 100,000 per mm3
- •4.Any of the following serum chemistry abnormalities:Total bilirubin > 1.5 × ULN,AST or ALT > 2.5 × ULN (or > 5 x ULN for subjects with liver metastasis),GGT > 2.5 x ULN (or > 5 x ULN for subjects with liver metastasis),Alkaline Phosphatase > 2.5 x ULN (or > 5 x ULN for subjects with liver or bone metastasis),Serum albumin < 3.0 g/dL,Creatinine > 1.5 × ULN,Proteinuria > 2.5 g/24 hours or 3+ with urine dipstick,Any other ≥ Grade 3 laboratory abnormality at baseline (other than those listed above)
- •5.Significant cardiovascular disease, including:Active clinically symptomatic left ventricular failure,Active hypertension (diastolic blood pressure > 100 mmHg).Subjects with a history of hypertension must have been on stable doses of anti-hypertensive drugs for ≥ 4 weeks,Uncontrolled hypertension:Blood pressure >140/90 mmHg on 2 or more antihypertensive medications,Myocardial infarction within 3 months prior to administration of first dose of study drug
- •6.Subjects with delayed healing of wounds, ulcers, and/or bone fractures
- •7.Known pulmonary hypertension or pneumonitis
- •8.Serious/active infection or infection requiring parenteral antibiotics
- •9.Inadequate recovery from any prior surgical procedure or major surgical procedure within 6 weeks prior to administration of first dose of study drug
- •10.Inability to comply with protocol requirements
- •11.Ongoing hemoptysis or history of clinically significant bleeding
- •12.Cerebrovascular accident within 12 months prior to administration of first dose of study drug , peripheral vascular disease with claudication on walking less than 1 block, life-threatening lingual angioedema or history of clinically significant angioedema
- •13.Deep venous thrombosis or pulmonary embolus within 6 months prior to administration of first dose of study drug and/or ongoing need for full-dose oral or parenteral anticoagulation
- •14.Subjects with a ?currently active? second primary malignancy other than non-melanoma skin cancers. Subjects are not considered to have a ?currently active? malignancy if they have completed anti-cancer therapy and are considered by their physician to be < 30% risk of relapse.
- •15.Pregnant or lactating women (a pregnancy test is required at screening); all male and female fertile subjects must use adequate contraception (barrier method) while on study and for 3 months thereafter. (Note: Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are not considered effective for this study.)
- •16.Known concomitant genetic or acquired immune suppression disease such as HIV
研究者
相似试验
招募中
1 期
A Phase 1/2, Open-Label, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Intravenous Doses of BMN 351 in Participants with Duchenne Muscular DystrophyMedDRA version: 20.0Level: PTClassification code: 10013801Term: Duchenne muscular dystrophy Class: 100000004850Duchenne Muscular DystrophyCTIS2023-506737-30-00Biomarin Pharmaceutical Inc.18
进行中（未招募）
1 期
A Phase 1/ 2 Study of the Oral Form of MLN9708 with Melphalan and Prednisone for Patients with Newly Diagnosed Multiple Myelomaewly diagnosed multiple myelomaMedDRA version: 16.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2010-023772-71-CZMillennium Pharmaceuticals, Inc158
进行中（未招募）
1 期
An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of MLN9708, a Next-Generation Proteasome Inhibitor, Administered in Combination with a Standard Care Regimen of Melphalan and Prednisone in Patients With Newly-Diagnosed Multiple Myeloma Requiring Systemic Treatment.Estudio de fase 1/2, de aumento de dosis, abierto, de la formulación oral de MLN9708, un inhibidor de proteosoma de nueva generación, administrado en combinación con un régimen habitual de melfalán y prednisona en pacientes con mieloma múltiple de nuevo diagnóstico que precisan tratamiento sistémico -mieloma múltiple de nuevo diagnósticoMedDRA version: 12.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2010-023772-71-ESMillennium Pharmaceuticals, Inc163
进行中（未招募）
不适用
A Phase 1/ 2 Study of the Oral Form of MLN9708 with Melphalan and Prednisone for Patients with Newly Diagnosed Multiple Myelomaewly diagnosed multiple myelomaMedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023772-71-ITMILLENNIUM PHARMACEUTICALS, INC.163
进行中（未招募）
1 期
A Phase 1/ 2 Study of the Oral Form of MLN9708 with Melphalan and Prednisone for Patients with Newly Diagnosed Multiple MyelomaEUCTR2010-023772-71-GBMillennium Pharmaceuticals, Inc61