EUCTR2009-011217-24-GB进行中（未招募）1 期
A Phase 1b/2, Multicenter, Open-label, Dose-escalation and Confirmation Study of Eribulin in Combination with Capecitabine
Eisai Ltd0 个研究点目标入组 76 人开始时间: 2009年8月21日最近更新:
适应症
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
- 76
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
入选标准
- •Subjects in Dose-escalation cohorts (Phase 1b):
- •1) Histologically or cytologically confirmed cancer that is advanced and/or
- •2) Resistant/refractory to approved therapies (defined as progressive
- •disease during or within 6 months after the last anti-cancer therapy) or
- •for whom single agent capecitabine at this dose level and schedule
- •would be a reasonable treatment option in the opinion of the investigator
- •3) Eastern Cooperative Oncology Group (ECOG) performance status (PS)
- •4) For subjects that previously received capecitabine all capecitabine
- •related toxicities must have completely resolved.
- •Subjects in Dose-confirmation cohorts (Phase 2):
- •1) Histologically or cytologically confirmed carcinoma of the breast that is
- •advanced and/or metastatic
- •2) Received up to three prior chemotherapy regimens in any setting
- •(sequential neo-adjuvant/adjuvant treatment counting as one regimen)
- •3) Chemotherapy regimens must have included an anthracycline (unless
- •anthracycline containing chemotherapy is inappropriate) and a taxane,
- •either in combination or in separate regimens
- •4) No prior treatment with capecitabine in any setting
- •5) At least one lesion of = 1.5cm in longest diameter for non-lymph nodes
- •and =1.5cm in shortest diameter for lymph nodes which is serially
- •measurable according to the Response Evaluation Criteria in Solid
- •Tumors (RECIST) version 1.1
- •6) ECOG-PS 0 or 1
- •General inclusion criteria:
- •1) Adequate bone marrow function:
- •absolute neutrophil count (ANC) = 1.5 x 109/L, hemoglobin = 10.0 g/dL
- •(this may have been corrected by growth factor or transfusion), and
- •platelet count = 100 x 109/L
- •2) Adequate liver function as evidenced by bilirubin = 1.5 times the upper
- •limits of normal (ULN) and alkaline phosphatase, alanine
- •aminotransferase (ALT), and aspartate aminotransferase (AST)
- •= 3 x ULN (in the case of liver metastases = 5 x ULN)
- •3) Adequate renal function as evidenced by calculated creatinine clearance
- •= 50 mL/min as per the Cockcroft-Gault formula or radioisotope
- •measurement
- •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 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1) Suspected dihydropyrimidine dehydrogenase (DPD) deficiency
- •2) Prior participation in an eribulin clinical study, even if not assigned to
- •eribulin treatment
- •3) Pre-existing neuropathy > Grade 2
- •4) Subjects with brain or subdural metastases are not eligible, unless they
- •have completed local therapy and have discontinued the use of
- •corticosteroids for this indication for at least 4 weeks before starting
- •study treatment. Any symptoms attributed to brain metastases must be
- •stable for at least 4 weeks before starting study treatment; radiographic
- •stability should be determined by comparing contrast-enhanced
- •computed tomography (CT) or magnetic resonance imaging (MRI) brain
- •scan performed during screening to a prior scan performed at least 4
- •weeks earlier.
- •5) Electrocardiogram (ECG) with QTc interval > 470 msec
研究者
相似试验
进行中（未招募）
不适用
A clinical trial to determine the most suitable dose of a combination of eribulin and capecitabine for use in late stage breast cancer patientsEUCTR2009-011217-24-BGEisai Limited76
进行中（未招募）
1 期
A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma and Head and Neck CancerMetastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaMedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-004461-47-DEDynavax Technologies Corporation235
已完成
1 期
A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination with Other Treatments in Subjects with Multiple MyelomaMultiple myeloma (MM)JPRN-jRCT2080224873Bristol-Myers Squibb K.K.41
进行中（未招募）
1 期
A study on NKTR-255 in combination with Cetuximab as salvage treatment for Solid TumorsRelapsed or refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or colorectal carcinoma (CRC)MedDRA version: 20.0Level: LLTClassification code 10009963Term: Colon carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10007336Term: Carcinoma colon recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 22.0Level: LLTClassification code 10082179Term: Squamous cell carcinoma of head and neck metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-002177-25-ESektar Therapeutics78
进行中（未招募）
1 期
A study on NKTR-255 in combination with Cetuximab as salvage treatment for Solid TumorsRelapsed or refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or colorectal carcinoma (CRC)MedDRA version: 22.0Level: LLTClassification code 10082179Term: Squamous cell carcinoma of head and neck metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10009963Term: Colon carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10007336Term: Carcinoma colon recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-002177-25-ITEKTAR THERAPEUTICS78