CTRI/2021/10/037247招募中3 期
A Multicenter, Randomized, Double blind, Parallel, Phase III Global Study to Assess the Efficacy and Safety of BP01 (Bevacizumab) when compared to Avastin®-EU in Combination with Carboplatin and Paclitaxel during Induction phase and Bevacizumab alone during the Maintenance phase in patients with newly diagnosed or recurrent Stage IIIB/IV Non Squamous (ns) Non-Small Cell Lung Cancer (NSCLC).
CURATEQ BIOLOGICS PRIVATE LIMITED India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Signed informed consent obtained prior to initiation of any study specific procedures
- •2.Male and or female subjects aged 18 years to 70 years inclusive of both
- •3.Subjects with histologic or cytologic diagnosis of nsNSCLC with negative or unknown sensitizing epidermal growth factor receptor mutation and documented negative or unknown anaplastic lymphoma kinase translocation
- •4.Subjects with newly diagnosed or recurrent Stage IIIB or IV ns NSCLC
- •5.Subjects must have at least 1 Uni dimensional measurable target lesion as per RECIST v1.1
- •6.Subjects with ECOG PS 0 or 1 at the time of screening and prior to first infusion
- •7.Subjects who are newly diagnosed should not have received any prior chemotherapy or targeted therapy
- •8.Subjects should not have received any immunotherapy or biological therapy for their disease
- •9.Subjects received prior adjuvant chemotherapy for NSCLC is permitted if completed 6 months prior to randomization
- •10.Subjects received prior radiation therapy if completed 4 weeks prior to randomization
- •11.Subjects must have a baseline scan of the chest abdomen and other disease sites as clinically indicated to assess disease burden performed within 21 days prior to randomization
- •12.Subjects with life expectancy of at least 6 months
- •13.Subjects must have adequate hepatic renal and hematologic function defined as
- •14.Subjects who has liver and/ or bone metastasis must have adequate organ function
- •15.Female subjects of child-bearing potential must be non-lactating and have a negative serum pregnancy test at the time of screening
- •16.Female subjects of childbearing potential agree to pregnancy prevention throughout the duration of study
- •17.Female subjects must agree to use of an effective method of contraception during study like Barrier methods Intrauterine device Hormone contraceptives
排除标准
- •1.Inability to comply with protocol procedures.
- •2.Subjects in another clinical trial or treatment with another investigational agent within 4 weeks of randomization, or five half-lives of investigational agent if longer than 4 weeks.
- •3.Subjects with known hypersensitivity to the active ingredients or any of the excipients or Chinese Hamster Ovary (CHO) cell products, or other recombinant human or humanized antibodies and combination chemotherapy.
- •4.Subjects who are having Central Nervous System (CNS) disease including brain and spinal cord metastases.
- •5.Subjects are on corticosteroids therapy except as premedication (must be off corticosteroids for at least 4 weeks prior to randomization).
- •6.Subjects are on anticoagulation treatment for thromboembolism.
- •7.Subjects were previously treated with vascular endothelial growth factor receptor (VEGFR) directed therapy.
- •8.Subjects have predominantly squamous cell histology NSCLC and Small Cell Lung Cancer (SCLC).
- •9.Subjects have concomitant systemic disorder (Hepatitis B, Hepatitis C, or human immunodeficiency virus).
- •10.Female subjects who are pregnant or breastfeeding.
- •11.Subjects with prior major surgery, open biopsy, open pleurodesis, or significant traumatic injury within 4 weeks prior to randomization or have an anticipated need for major surgery during study.
- •12.Subjects having core biopsy, other minor surgical procedure, excluding placement of vascular access device, closed pleurodesis, thoracentesis, mediastinoscopy, taken within 1 week of randomization.
- •13.Subjects have history of stroke or transient ischemic attack with-in 6 months prior to randomization.
- •14.Subjects have prior history of hypertensive crisis or hypertensive encephalaopathy.
- •15.Subjects with previous malignancy within 5 years of randomization (other than superficial basal cell and superficial squamous cell cancer, or uterine, cervix, bladder, or prostate cancer).
- •16.Subjects with uncontrolled hypertension (defined as systolic blood pressure >150 and/or diastolic > 100 mm Hg on antihypertensive medications).
- •17.Subjects with clinically significant cardiovascular disease: history of myocardial infarction, angina, or heart disease by NYHA Class II, III, or IV, within 6 months prior to randomization
- •18.Subjects with a history of significant vascular event within 6 months prior to randomization (including, but not limited to myocardial infarction and stroke or transient ischemic attack).
- •19.Subjects with known bleeding diathesis or significant coagulopathy within 3 months prior to randomization.
- •20.Subjects with a history of abdominal fistula, gastro-intestinal perforation, intraabdominal abscess within 6 months of randomization.
- •21.Subjects with a non-healing wound, active ulcer, inflammatory bowel disease or untreated bone fracture.
- •22.Subjects with history of hemoptysis (approximately > 2.5 mL or a half teaspoon) within three months prior to randomization.
- •23.Subjects with tumour invading or compressing major blood vessels.
- •24.Subjects with history or presence of arterial/venous thromboembolic events.
- •25.Subjects with history or presence of Posterior Reversible Encep-halopathy Syndrome (PRES).
- •26.Subjects with presence of Osteonecrosis of the jaw.
- •27.Subjects with known current alcohol/ drugs of abuse th
研究者
相似试验
进行中（未招募）
2 期
Evaluation of combination of Minoxidil (5%) and Adenosine (1%) topical solution in the treatment of Hair LossCTRI/2019/10/021835Dr Reddys Laboratories Limited
进行中（未招募）
1 期
A Multicenter, Randomised, Double blind, Parallel, Phase III Global Study to Assess the Efficacy and Safety of BP01 (Bevacizumab) when compared to Avastin®-EU in Combination with Carboplatin and Paclitaxel during Induction phase and Bevacizumab alone during the Maintenance phase in patients with newly diagnosed or recurrent Stage IIIB/IV Non Squamous (ns) Non-Small Cell Lung Cancer (NSCLC).ewly diagnosed or recurrent Stage IIIB/IV Non Squamous (ns) Non-Small Cell Lung Cancer (NSCLC).MedDRA version: 20.0Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-005618-16-HUCuraTeQ Biologics Private Limited648
进行中（未招募）
不适用
A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACERMedDRA version: 8.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid ArthritisEUCTR2006-002216-10-HUProcter & Gamble Pharmaceuticals270
进行中（未招募）
不适用
A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACERMedDRA version: 8.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid ArthritisEUCTR2006-002216-10-NLProcter & Gamble Pharmaceuticals270
进行中（未招募）
不适用
A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACERRheumatoid ArthritisEUCTR2006-002216-10-CZProcter & Gamble Pharmaceuticals270