NL-OMON50631已完成3 期
A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma. - CanStem111P
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients must fulfill all of the following criteria to be eligible for
- •admission to the study:, 4.1.1. Written, signed consent for trial participation
- •must be obtained from the patient appropriately in accordance with applicable
- •ICH guidelines and local and regulatory requirements prior to the performance
- •of any study specific procedure., 4.1.2. Must have histologically or
- •cytologically confirmed advanced PDAC that is metastatic. The definitive
- •diagnosis of metastatic PDAC will be made by integrating the histopathological
- •data within the context of the clinical and radiographic data. Patients with
- •islet cell neoplasms are excluded., 4.1.3. Must not have previously received
- •chemotherapy or any investigational agent for the treatment of PDAC.
- •* A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in
- •the adjuvant setting is allowed for as long as last dose was administered > 6
- •months prior to randomization and no lingering toxicities are present., 4.1.4.
- •Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and
- •recommended by the Investigator., 4.1.5. Patient has one or more metastatic
- •tumors evaluable by CT scan with contrast (or MRI, if patient is allergic to CT
- •contrast media) per RECIST 1.1. Imaging investigations including CT/MRI of
- •chest/abdomen/pelvis or other scans as necessary to document all sites of
- •disease must be performed within 14 days prior to randomization. Qualifying
- •scans performed as part of standard of care prior to patient signature of the
- •study informed consent will be acceptable as baseline scanning as long as
- •scanning is performed < 14 days prior to randomization., 4.1.6. Must have ECOG
- •Performance Status of 0 or 1, assessed within 14 days prior to randomization.
- •Two observers qualified to perform assessment of the performance status will be
- •required to perform this assessment. If discrepant, the one with the most
- •deteriorated performance status will be considered true.
- •* Patients must not require any help with activities of daily living (ADLs),
- •including eating, dressing, washing or using the toilet.
- •* Patients must not need to stay in bed or chair for 50% or more of waking
- •* Patients with factors that limit accurate assessment of performance status
- •will not be eligible for the study. This includes but is not limited to
- •patients with pre-existing conditions preventing them from full mobility
- •(including but not limited to spinal or orthopedic conditions, amputees, morbid
- •obesity defined by BMI > 40)., 4.1.7. Must have life-expectancy of > 12 weeks.,
- •4.1.8. Must be * 18 years of age.
- •* Due to increased risk of sepsis in patients >80 years old, candidate patients
- •in this age group should be thoroughly evaluated prior to study randomization
- •to ensure they are fit to receive chemotherapy. In addition to all of the
- •inclusion/exclusion criteria listed, clinical judgment should be used regarding
- •patients* susceptibility to infection (including but not limited to presence of
- •ascites or diabetes mellitus increasing risk of infection). Furthermore, the
- •expected stability of their performance status while receiving repeat weekly
- •chemotherapy cycles should be given special attention. Patients in this age
- •group should not be randomized on the study should there be any hesitation on
- •any of these consideratio
排除标准
- •Patients who fulfill any of the following criteria are not eligible for
- •admission to the study:, 4.2.1. Patients with no evidence of metastatic disease
- •as well as patients with a local recurrence following surgical resection of
- •primary lesion., 4.2.2. Patient has experienced a decline in ECOG performance
- •status between Baseline visit and within 72 hours prior to randomization.,
- •4.2.3. Patient has a > 20% decrease in serum albumin level between Baseline
- •visit and within 72 hours prior to randomization., 4.2.4 Patient has a > 10%
- •decrease in weight between Baseline visit and within 72 hours prior to
- •randomization, 4.2.5. Any prior anti-cancer chemotherapy, biologic or
- •investigational therapy for PDAC.
- •a. Patients receiving immunotherapy for non-cancer related treatment within * 4
- •weeks of first planned dose of study treatment will be excluded.
- •b. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in
- •the adjuvant setting is allowed for as long as last dose was administered > 6
- •months prior to randomization., 4.2.6. Major surgery within 4 weeks prior to
- •randomization., 4.2.7. Any known brain or leptomeningeal metastases are
- •excluded, even if treated., 4.2.8. Patients with clinically significant ascites
- •or pleural effusions., 4.2.9. 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., 4.2.10. 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)., 4.2.11. Unable or unwilling to swallow BBI-608
- •capsules daily., 4.2.12. 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.
- •a. History of cardiac disease: congestive heart failure (CHF) > NYHA Class II;
- •active coronary artery disease, myocardial infarction or coronary stenting
- •within 6 months prior to randomization; unevaluated new onset angina within 3
- •months or unstable angina (angina symptoms at rest) or cardiac arrhythmias
- •requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- •b. Current uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg
- •or diastolic pressure > 90 mmHg despite optimal medical management) as well as
- •prior history of hypertensive crisis or hypertensive encephalopathy.
- •c. Significant vascular disease (e.g., aortic aneurysm, aortic dissection,
- •symptomatic peripheral vascular disease including claudication, Leo Buerger*s
- •disease). Treated peripheral vascular disease that is stable for at least 6
- •months is allowed.
- •d. Evidence of bleeding diathesis or clinically significant coagulopathy.
- •e. Major surgical procedure (including open biopsy, significant t
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