EUCTR2011-000850-48-HU进行中（未招募）1 期
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab plus Etoposide/Platinum versus Etoposide/Platinum in Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)Revised Protocol 01 incorporating administrative letter 04 and protocol amendment 04 (dated 09-Feb-2012).
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
- 1,100
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) Signed Written Informed Consent
- •a) Willing and able to provide informed consent.
- •2) Target Population
- •a) Subjects with SCLC documented by histology or cytology from brushing, washing or
- •needle aspiration of a defined lesion but not from sputum cytology alone.
- •b) Subjects must present with extensive stage disease (VALG classification, and defined as
- •disease beyond ipsilateral hemithorax which may include malignant pleural effusion or
- •pericardial effusion or hematogenous metastases)60,61.
- •c) Eastern Cooperative Oncology Group (ECOG) performance status ? 1.
- •d) Accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at
- •the participating centers.
- •e) Re-enrollment: permitted for a subject who has discontinued the study as a pretreatment
- •failure (ie, subject has not been randomized / has not been treated). If re-enrolled, the
- •subject must be re-consented.
- •3) Age and Reproductive Status
- •a) Men and Women ? 18 years of age.
- •b) Women of childbearing potential (WOCBP) must use method(s) of contraception as
- •indicated in the Informed Consent Form. For a teratogenic study drug, and/or when there
- •is insufficient information to assess teratogenicity (preclinical studies have not been
- •done), a highly effective method(s) of contraception (failure rate of less than 1% per
- •year) is required. The individual methods of contraception and duration should be
- •determined in consultation with the investigator. WOCBP must agree to follow
- •instructions for method(s) of contraception for the duration of treatment with blinded
- •study drug plus 5 half-lives (75 days) plus 30 days (duration of ovulatory cycle) for a
- •total of 105 days post completion of blinded study therapy.
- •c) Women must not be breastfeeding.
- •d) Sexually active fertile men must use effective birth control if their partners are WOCBP.
- •Men that are sexually active with WOCBP must follow instructions for birth control for
- •the entire duration of treatment with blinded study therapy, plus 5 half-lives of
- •ipilimumab (75 days) plus 90 days (duration of sperm turnover) for a total of 165 days
- •post completion of blinded study therapy.
- •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 660
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 440
排除标准
- •1) Target Disease Exceptions
- •a) CNS metastases, unless non-symptomatic (ie, no neurological deficit, epilepsy or other signs and symptoms typical of CNS metastases), and not requiring treatment with steroids or anticonvulsant medications. In addition, if treated with radiation therapy, CNS metastases must be stable with no evidence of progression on scans for at least 30 days from initial radiologic diagnosis of CNS metastases.
- •b) Pleural effusion which cannot be controlled with appropriate interventions.
- •2) Medical History and Concurrent Diseases
- •a) Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment such as: i) Ulcerative colitis and Crohn’s disease, ii) Rheumatoid arthritis, systemic progressive sclerosis (scleroderma),
- •iii) Systemic Lupus Erythematosus, iv) Autoimmune vasculitis (eg, Wegener’s Granulomatosis).
- •b) Subjects with history of motor neuropathy considered of autoimmune origin (eg, Guillain-Barré Syndrome).
- •c) Subjects with a history of toxic epidermal necrolysis (TEN).
- •d) Interstitial pneumonia or pulmonary fibrosis.
- •e) Paraneoplastic autoimmune syndrome
- •f) Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or completing questionnaires.
- •g) Serious uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol therapy.
- •h) Prior malignancy, active within 5 years, except for locally curable cancers that have been apparently cured and need no subsequent therapy, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
- •i) HIV, active Hepatitis B, or active Hepatitis C infection, based on testing performed during the CA184156 screening period. In the event of a positive HIV or anti-HCV antibody test, results of confirmatory testing must be awaited before randomization.
- •j) Prior systemic therapy for lung cancer, including vaccines and other targeted therapies.
- •i) Prior radiation therapy or loco-regional surgeries are allowed.
- •k) Subjects with = Grade 2 peripheral neuropathy.
- •3) Physical and Laboratory Test Findings
- •a) Inadequate hematologic function defined by:
- •i) Absolute neutrophil count (ANC) < 1,500/mm3, or
- •ii) Platelet count < 100,000/mm3; or
- •iii) Hemoglobin level < 9 g/dL.
- •b) Inadequate hepatic function as defined by either:
- •i) Total bilirubin level = 2.5 times the ULN;
- •ii) AST and ALT levels = 2.5 times the ULN or = 5 times the ULN if liver metastases are present.
- •c) Inadequate renal function defined as calculated creatinine clearance < 50 ml/min based on the standard Cockroft and Gault formula.
- •d) Sodium (Na) < 130 mmol/l.
- •4) Prohibited Treatments and/or Therapies
- •a) Chronic use of immuno-suppressive drugs (ie, corticosteroids used in the management of cancer or non-cancer related illnesses). Use of corticosteroids are allowed if used as premedication for chemotherapy administration or on-study management of an AE.
- •b) Any immunotherapy for the treatment of cancer.
- •c) Prior treatment with any inhibitor or agonist of T-cell co-stimulation.
- •5) Other Exclusion Criteria
- •a) Prisoners or subjects who are involuntarily incarcerated.
- •b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
研究者
相似试验
进行中（未招募）
1 期
A study to see how effective and safe NEO001 is when given together with the standard treatment in comparison to placebo together with the standard treatment in people with Light Chain (AL) Amyloidosis.ight chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossiaMedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disordersEUCTR2014-003865-11-DEProthena Therapeutics Limited260
进行中（未招募）
1 期
A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) AmyloidosisAL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, and hepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossiaMedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disordersEUCTR2021-000037-14-NLProthena Biosciences Limited220
进行中（未招募）
1 期
A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) AmyloidosisEUCTR2021-000037-14-HUProthena Biosciences Limited150
招募中
1 期
A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque PsoriasisCTIS2023-505841-22-00Takeda Development Center Americas Inc.600
招募中
1 期
A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) AmyloidosisAL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, and hepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossiaMedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disordersEUCTR2021-000037-14-CZProthena Biosciences Limited220