A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma. -

BOSTON BIOMEDICAL, INC.0 个研究点目标入组 1,132 人开始时间: 2018年10月19日最近更新: 2020年9月7日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: BOSTON BIOMEDICAL, INC.
入组人数: 1,132

研究概览入排标准研究者记录与标识符相似试验

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

•This study will enroll patients with histologically or cytologically confirmed adenocarcinoma of the pancreas that is metastatic (Stage IV).
•Patients with local recurrence following surgical resection will be excluded. At randomization, patients will have been diagnosed = or < 6 weeks prior to randomization and will not have received systemic
•chemotherapy for metastatic pancreatic adenocarcinoma previously (with a fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting allowed). Other inclusion criteria for all patients include: age = 18 years; ECOG performance status = 1; and adequate hepatic, renal, and bone-marrow function.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 680
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 452

排除标准

•-Patients with no evidence of metastatic disease as well as patients with a local recurrence following surgical resection of primary lesion.
•-Patient has experienced a decline in ECOG performance status between Baseline visit and within 72 hours prior to randomization.
•-Patient has a > or = 20% decrease in serum albumin level between Baseline visit and within 72 hours prior to randomization.
•-Any prior anti-cancer chemotherapy, biologic or investigational therapy for PDAC.
•-Major surgery within 4 weeks prior to randomization.
•-Any known brain or leptomeningeal metastases are excluded, even if treated.
•-Patients with clinically significant ascites.
•-Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of BBI-608 or while undergoing treatment with nab-paclitaxel and
•gemcitabine and for 180 days after the last dose of nab-paclitaxel and gemcitabine.
•-Gastrointestinal disorder(s) which, in the opinion of the Principal Investigator, would significantly impede the absorption of an oral agent (e.g. active Crohn's disease, ulcerative colitis, extensive gastric and
•small intestine resection).
•-Unable or unwilling to swallow BBI-608 capsules daily.
•-Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds,
•symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness
•of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
•-Known hypersensitivity to gemcitabine, taxanes or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the
•product or comparator SmPC or Prescribing Information.
•-Neurosensory neuropathy > or = grade 2 at baseline.
•-Abnormal glucuronidation of bilirubin, known Gilbert's syndrome.
•-Uncontrolled chronic diarrhea > or = grade 2 at baseline.
•-Patients being treated with Warfarin.
•-Patients with active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy
•-Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated by surgery alone or surgery plus radiotherapy with no evidence of disease continuously for > or = 5 years.
•-Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
•-Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol, including patients with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol. Patients planning to take a vacation for 7 or
•more consecutive days during the course of the study are ineligible.

研究者

发起方

BOSTON BIOMEDICAL, INC.

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