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临床试验/NCT04046887
NCT04046887终止1 期

Phase I Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Patrick Joseph Loehrer Sr.1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年9月11日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
发起方
入组人数
14
试验地点
1
主要终点
Frequency of Dose Limiting Toxicities (DLTs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel in Pancreatic ductal adenocarcinoma (PDAC)

详细描述

This is a single-institution, prospective, phase I dose escalation trial of lonsurf combined with gemcitabine and nab-paclitaxel using the 3+3 design. This study will enroll 18 patients over 12-15 months.

Primary Objective To determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel

Secondary Objectives

  1. Examine safety and toxicity of the combination
  2. Estimate response rate to the combination
  3. Estimate median overall survival (mOS) of the treated population
  4. Estimate median progression free survival (mPFS) of the treated population
  5. Estimate disease control rate (DCR) at 8 weeks
  6. Evaluate quality of life while receiving the combination therapy

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •≥ 18 years old at the time of informed consent
  • •Ability to provide written informed consent and HIPAA authorization
  • •Untreated locally advanced Pancreatic Ductal Adenocarcinoma (PDAC) as defined by National Comprehensive Cancer Network (NCCN) guidelines or, untreated metastatic PDAC (prior adjuvant therapy is permitted if it's been greater than 6 months since completion)
  • •Histologically or cytologically confirmed PDAC
  • •Confirmed PDAC that is measurable or evaluable per RECIST 1.1
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • •Gastrointestinal symptoms (nausea, vomiting, and diarrhea) of Grade 1 or less
  • •Adequate organ function as defined by:
  • •Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x upper limits of normal (ULN)
  • •Total bilirubin level ≤ 1.5 x ULN
  • •Creatinine level < 1.0 x ULN or creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above or below the institutional normal (as determined by Cockcroft-Gault equation). For patients with a Body Mass Index (BMI) > 30 kg/m2, lean body weight should be used to calculate the glomerular filtration rate (GFR).
  • •Hemoglobin (Hgb) ≥ 9 g/dl
  • •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • •Platelets ≥ 100 x 109/L
  • •Acceptable coagulation studies as demonstrated by prothrombin time (PT) within normal limits (+/-15%) unless they are on anticoagulation therapy
  • •Life expectancy estimated at ≥ 3 months
  • •Women of childbearing potential definition (WOCBP) must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of study treatment.
  • •Any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) is classified as WOCBP if she meets the following criteria:
  • •Has not undergone a hysterectomy or bilateral oophorectomy; or
  • •Has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months).
  • •WOCBP and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 8 weeks after the end of treatment.

排除标准

  • •Neuropathy > Grade 1 at baseline
  • •Prior systemic chemotherapy for any other malignancy (aside from adjuvant therapy for PDAC) in the last 3 years
  • •Active malignancy other than PDAC (other than adequately treated cervical or vulvar carcinoma in situ, treated basal cell or squamous carcinoma of the skin, superficial bladder tumors (Ta, Tis & T1), ductal carcinoma in situ (DCIS) of the breast and low grade prostate cancer. Any cancer curatively treated >3 years prior to entry with no clinical evidence of recurrence is permitted)
  • •Prior exposure to nab-paclitaxel, paclitaxel, or other taxanes
  • •History of bowel obstruction in the preceding 3 months of therapy, including gastric outlet obstruction related to PDAC
  • •Large, uncontrolled ascites requiring paracentesis
  • •Major surgery, other than diagnostic or laparoscopic surgery, within 4 weeks prior to first dose. (Port placement would not be considered a surgery.)
  • •Any known untreated brain metastases including leptomeningeal metastases
  • •Pregnant or breastfeeding
  • •Significant gastrointestinal disorder(s) that would, in the opinion of the Principal Investigator, prevent absorption of an orally available agent (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection, and small intestinal resection)
  • •Uncontrolled chronic diarrhea > Grade 1 at baseline.
  • •Uncontrolled intercurrent illness including, but not limited to uncontrolled active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, significant pulmonary disease, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  • •Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • •History of posterior reversible encephalopathy syndrome
  • •Enrollment on any additional investigational agent study
  • •Known hypersensitivity to gemcitabine or taxanes
  • •Significant cardiac disease including the following: unstable angina, New York Heart Association class III-IV congestive heart failure, myocardial infarction < 6 months prior to study enrollment
  • •History of hemolytic-uremic syndrome
  • •Known infection with Human Immunodeficiency Virus (HIV) and/or active infection with hepatitis B or hepatitis C

研究组 & 干预措施

Combination of lonsurf + gemcitabine + nab-paclitaxel

Experimental

干预措施: Lonsurf (Drug)

Combination of lonsurf + gemcitabine + nab-paclitaxel

Experimental

干预措施: Gemcitabine (Drug)

Combination of lonsurf + gemcitabine + nab-paclitaxel

Experimental

干预措施: Nab-Paclitaxel (Drug)

结局指标

主要结局

Frequency of Dose Limiting Toxicities (DLTs)

时间窗: 28 days (Cycle 1)

Number of DLTs observed

次要结局

  • Frequency of adverse events in the safety evaluable population(from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years))
  • Response rate to the combination of lonsurf, gemcitabine, and nab-paclitaxel in the efficacy evaluable population(from start of treatment until treatment discontinuation (i.e. up to 2 years))
  • Median Overall Survival (mOS) of the treated population(from start of treatment until death or last known follow up (i.e up to 2 years))
  • Median Progression-free Survival (mPFS) of the treated population(from start of treatment until disease progression or last follow up (i.e. up to 2 years))
  • Disease control rate (DCR)(8 weeks)
  • European Organization for Research and Treatment of Cancer quality of life questionnaire(Day 1 of each cycle(each cycle is 28 days),from start of treatment until disease progression or discontinuation of treatment (i.e. up to 2 years))

研究者

发起方
Patrick Joseph Loehrer Sr.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Patrick Joseph Loehrer Sr.

Distinguished Professor of Medicine

Indiana University

研究点 (1)

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