EUCTR2004-002016-28-ES进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy (RT/CT)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Ltd
- 入组人数
- 315
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
- •- Histologically documented squamous cell carcinoma.
- •- Subjects with newly diagnosed (locally advanced) resected (R0, R1) HNC (American Joint Committee on Cancer [AJCC] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx and suitable to receive adjuvant concurrent RT/CT.
- •- Radiation treatment field to receive planned dose of at least 50 Gy to areas of the oral cavity / oropharynx mucosa that can be visualized by non-instrumental oral inspection.
- •- Subjects with larynx or hypopharynx tumors are eligible only if the radiation oncologist anticipates at least 2 of the 9 anatomical areas in the oral cavity [Mucositis Assessments] will receive a total dose of 50 Gy or more.
- •- Signed informed consent.
- •- Subject is 18 years of age or older.
- •- ECOG performance status (PS) less than or equal to 2.
- •- Planned interval < 6 calendar days between randomization and the first dose of RT.
- •Baseline laboratory assessments:
- •- Hemoglobin (Hgb) more than or equal to 10g/dL
- •- White blood count (WBC) > 3.5 x 10E9/L or
- •- Absolute neutrophil count (ANC) > 1.5 x 10E9/L.
- •- Platelet count more than or equal to 100 x 10E9/L.
- •- Serum bilirubin less than or equal to 1.5 x institutional upper limits of normal (ULN).
- •- Serum creatinine less than or equal to 2.0 mg/dL; Subjects with a serum creatinine more than or equal to 1.4 mg/dL and less than or equal to 2.0 mg/dL need to demonstrate a 24-hr urinary creatinine clearance more than or equal to 50 mL/min.
- •- Serum or urine pregnancy test: Negative
- •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
- •- Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors.
- •- Metastatic disease (M1) / Stage IV C.
- •- Presence or history of any other primary malignancy.
- •- History of pancreatitis.
- •- Prior radiotherapy to the site of disease.
- •- Prior chemotherapy.
- •- Other investigational procedures.
- •- Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is for long-term follow-up/survival data.
- •- Pregnant or breast-feeding women.
- •- Refusal to use adequate contraceptive devices during treatment phase.
- •- Known sensitivity to any of the products administered during dosing, including E coli-derived products.
- •- Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- •- Previous treatment on this study or with other keratinocyte growth factors.
- •- Compromised ability of the subject to give written informed consent and/or to comply with study procedures.
- •- Refusal to give written informed consent to participate in this study and to sign the hospital information release form.
- •- Unwilling or unable to complete the patient-reported outcome questionnaires.
- •- Psychological, social, familial, or geographical reasons that would prevent regular follow-up.
研究者
相似试验
进行中（未招募）
不适用
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy (RT/CT)EUCTR2004-002016-28-ITAMGE
进行中（未招募）
1 期
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseEUCTR2010-022760-12-ITJanssen-Cilag International N.V.1,281
进行中（未招募）
不适用
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate theEfficacy and Safety of Weekly Doses of Palifermin (Recombinant HumanKeratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis inSubjects With Advanced Head and Neck Cancer Receiving Radiotherapy WithConcurrent Chemotherapy (RT/CT). - Palifermin 2002402EUCTR2005-000213-35-ITAMGEN S.P.A.180
进行中（未招募）
1 期
An Phase 3 clinical study comparing a vector transferring the gene for Glucose-6-Phosphatase with placebo in adults with Glycogen Storage Disease Type Ia.EUCTR2020-004184-12-PTltragenyx Pharmaceutical Inc.50
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD TherapyMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Psoriatic ArthritisEUCTR2019-002021-29-ESGilead Sciences Inc.390