NCT03468335已完成3 期
Second-line Therapy With Nal-IRI After Failure Gemcitabine/Nab-paclitaxel in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 35
- 主要终点
- Time to Treatment Failure of second-line treatment (TTF2)
研究概览
简要总结
Second-line therapy with Nal-IRI after failure gemcitabine/nab-paclitaxel in advanced pancreatic cancer - predictive role of 1st-line therapy
详细描述
Research hypothesis:
Patients profit from 2nd-line therapy with Nal-IRI if they also had a benefit from 1st-line treatment. Benefit from treatment (either 1st or 2nd-line) will be defined as a patient specific Time-To-Treatment Failure (TTF) which is in the upper third of the distribution of TTF values of the studied population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Written informed consent including participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •Clinical indication for a 2nd-line systemic therapy according to current standard-of-care.
- •Age ≥ 18 years at time of study entry
- •Patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma
- •Imaging of evaluable lesions within 2 weeks of inclusion (either sonography, X-ray, CT scans, MRI)
- •ECOG performance status 0-2
- •One line of systemic gemcitabine/Nab-paclitaxel -based therapy for advanced disease (irrespective of prior adjuvant therapy) OR Previous adjuvant gemcitabine/Nab-paclitaxel-based chemotherapy with documented progression less than 6 months after termination
- •Detailed documentation of prior therapy (duration, dose-intensity, maximum toxicity, reason for discontinuation)
- •Adequate blood count, liver-enzymes, and renal function:
- •neutrophil count > 1.5 x 10^6/mL
- •Platelet count ≥ 100 x 10^9/L (≥100,000 per mm^3)
- •AST (SGOT)/ALT (SGPT) ≤ 5 x institutional upper limit of normal
- •bilirubin ≤1.5 ULN (<3 x ULN in patients with confirmed mechanical cholestasis)
- •Creatinine Clearance CLcr ≥ 30 mL/min
- •Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
排除标准
- •Medical criteria:
- •Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
- •Active uncontrolled infection, chronic infectious diseases, immune deficiency syndromes
- •Premalignant hematologic disorders, e.g. myelodysplastic syndrome
- •Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
- •Prior (<3 years) or concurrent malignancy (other than biliary-tract cancer) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial urinary bladder tumor [Ta, Tis and T1].
- •Pre-existing lung disease of clinical significance or with impact on performance status
- •History or clinical evidence of CNS metastases
- •Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria:
- •I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of study treament. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases
- •Allogeneic transplantation requiring immunosuppressive therapy or other major immunosuppressive therapy
- •Severe non-healing wounds, ulcers or bone fractions
- •Evidence of bleeding diathesis or coagulopathy
- •Major surgical procedures, except open biopsy, or significant traumatic injury within 28 days prior to star of study treatment, or anticipation of the need for major surgical procedure during the course of the study except for surgery of central intravenous line placement for chemotherapy administration.
- •Known Gilbert-Meulengracht syndrome
- •Known chronic hypoacusis, tinnitus or vertigo
- •Bone marrow depression (e.g., after radiation therapy)
- •Pernicious anemia and other megaloblastic anemias secondary to vitamin B12 deficiency
- •Severe impairment of hepatic function
- •Drug related criteria:
- •Medication that is known to interfere with any of the agents applied in the trial.
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •History of hypersensitivity to any of the study drugs or any of the constituents of the products.
- •Any other efficacious cancer treatment except protocol specified treatment at study start.
- •Safety criteria:
- •Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. Women of childbearing potential must have a negative pregnancy test (urine or serum β-HCG acc. to SOC) at Screening.
- •Methodological criteria:
- •Any experimental pretreatment for advanced disease
- •Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.
- •Previous enrollment in the present study (does not include screening failure).
- •Regulatory and ethical criteria:
- •Patient who might be dependent on the sponsor, site or the investigator
- •Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
研究组 & 干预措施
Single Arm
Other
Cancer treatment for PDAC:
- Nal-IRI (4.3 mg/ml) 70 mg/m2 as 1.5 hour infusion
- 5-FU 2400 mg/m2 as 46 hour infusion
- Folinic acid 400 mg/m2 as 0.5 hour infusion
- all on D1 of each cycle; Cycle q2w ± 5 days
Treatment until progressive disease or intolerable toxicity or withdrawal of consent.
干预措施: Irinotecan Liposomal Injection [Onivyde] (Drug)
结局指标
主要结局
Time to Treatment Failure of second-line treatment (TTF2)
时间窗: up to 6 month
Time-To-Treatment-Failure - (TTF2) is defined as date of signed ICF until permanent treatment discontinuation (or day of initially planned next cycle) due to progressive disease or unacceptable toxicity. Expected increase of the TTF2 by 50% in the cohort of patients with favorable TTF1 (TTF1 high: upper third of the patient population) as compared to patients with short TTF1 (TTF low: lowest third of the patient population)
次要结局
- Progression Free Survival (PFS)(up to 12 month)
- AEs / SAEs(up to 12 month)
- Overall survival (OS)(up to 12 month)
- Quality of Life (QoL) EORTC QLQ-C30(up to 6 month)
- Quality of Life (QoL) EORTC QLQ-PAN26(up to 6 month)
- Quality of Life (QoL) EORTC EQ-5D-5L(up to 6 month)
- Evaluation of time to definitive deterioration of QoL (TDD)(from date of baseline Scrore until date QoL Score deterioration, assessed up to 12 month)
- Growth modulation index (GMI)(up to 6 month)
研究者
研究点 (35)
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