EUCTR2021-002366-41-IT进行中（未招募）1 期
Phase II, multicenter, randomized, open-label study with MAP +/- denosumab regimen for the treatment of patients with metastatic osteosarcoma - AIEOP-ISG OsM+
ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA0 个研究点目标入组 112 人开始时间: 2021年10月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
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
- •- High-grade metastatic osteosarcoma
- •- Age at diagnosis = 12 years (or with skeletal maturity) and = 40 years
- •- ECOG Performance status = 2 or Lansky = 40%
- •- Adequate medullary, cardiac, liver and kidney function
- •- Female subjects of childbearing age must perform a pregnancy test before entering the study
- •- Written informed consent obtained from the patient/parent/legal representative
- •Are the trial subjects under 18? yes
- •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 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Medical contraindication to the use of the drugs provided for in the study
- •- Previous treatments with denosumab or other biphosphonates
- •- Mental or social conditions that do not guarantee adequate compliance with the protocol, proper home management of toxicity or an adequate understanding of participation in the study
- •- Lack of written informed consent
- •- Organ dysfunction
- •- Pregnancy or lactation
- •- Uncontrolled hypocalcemia with oral calcium supplementation
- •- Severe hypovitaminosis D
- •- Previous history or evidence of osteonecrosis of the jaw
- •- Dental contraindications to the use of denosumab
研究者
相似试验
招募中
1 期
Phase II, multicenter, randomized, open-label study of premenopausal women with luminal breast cancer investigating the effect of elacestrant (oral selective estrogen receptor degrader) with/without triptorelin on the estrogen receptor functional pathway and Ki67 proliferation. Preoperative trial - PremiÈRe.CTIS2023-503373-37-01Solti Group48
进行中（未招募）
不适用
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.Patients aged 6 months to <18 years, presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.MedDRA version: 14.1Level: LLTClassification code 10065868Term: Embryonal rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10061526Term: Malignant mesenchymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10065867Term: Alveolar rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10058387Term: Schwannoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10039494Term: Sarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10039024Term: Rhabdomyosarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10039022Term: RhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10039026Term: Rhabdomyosarcoma previously untreatedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10024189Term: LeiomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10042864Term: Synovial sarcoma metastaticSystem Organ Class: 10029104 - NeoplasmEUCTR2007-005017-19-Outside-EU/EEAF. Hoffmann-La Roche Ltd150
进行中（未招募）
1 期
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.EUCTR2007-005017-19-NLF. Hoffmann-La Roche Ltd154
进行中（未招募）
1 期
A study of Avastin (Bevacizumab) in Combination with Standard Chemotherapy in Children and Adolescents with SarcomaPatients aged 6 months to <18 years, presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.MedDRA version: 14.0 Level: PT Classification code 10039022 Term: Rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0 Level: LLT Classification code 10065867 Term: Alveolar rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0 Level: PT Classification code 10001882 Term: Alveolar soft part sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0 Level: LLT Classification code 10039494 Term: Sarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0 Level: LLT Classification code 10060651 Term: Malignant hemangiopericytoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0 Level: LLT Classification code 10065868 Term: Embryonal rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0 Level: LLT ClassEUCTR2007-005017-19-DEF. Hoffmann-La Roche Ltd154
进行中（未招募）
1 期
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.Patients aged 6 months to <18 years, presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.MedDRA version: 20.0 Level: PT Classification code 10061526 Term: Malignant mesenchymoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10065868 Term: Embryonal rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10065867 Term: Alveolar rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10058387 Term: Schwannoma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10039024 Term: Rhabdomyosarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10039494 Term: Sarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10039022 Term: RhabdomyosarcomaEUCTR2007-005017-19-BEF. Hoffmann-La Roche Ltd154