EUCTR2013-004516-21-AT进行中（未招募）1 期
An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1) - PANCRIT-1 (PANcreatic Cancer RadioImmunoTherapy Trial 1)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 333
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
- •1. Males or non-pregnant, non-lactating females = 18 years old, able to give signed written informed consent.
- •2. Histologically or cytologically confirmed adenocarcinoma of the pancreas.
- •3. Stage IV (metastatic) disease documented by CT imaging (MRI if patient allergic to contrast media) 90Y-clivatuzumab tetraxetan
- •4. Received at least two prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease.
- •5. At least one of the prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease must have contained gemcitabine and have met the following criteria:
- •o Completed at least one cycle of the treatment
- •o Received gemcitabine administered at a minimum dose of 800 mg/m2 per
- •week in the first cycle of treatment
- •o Progressed while receiving this gemcitabine regimen or within 3 months of
- •completing gemcitabine
- •o Progression was documented,
- •? Preferentially radiologically by tumor growth or new lesions, or by
- •? Clear symptomatic deterioration supported by at least two of the
- •following clinical criteria: = 10% worsening in KPS or = 1
- •worsening in ECOG; increasing weakness or fatigue; progressive
- •weight loss; new/worsening pain requiring increased pain
- •medication; new/worsening jaundice, nausea, or vomiting;
- •new/worsening ascites or pleural effusions; other physical or
- •laboratory findings consistent with disease progression.
- •6. Adequate performance status (Karnofsky Performance Status = 70%)
- •7. Expected survival = 3 months.
- •8. Adequate hematology without ongoing transfusional support (hemoglobin = 9g/dL, ANC = 1.5 x 10^9/L, platelets = 100 x10^9/L).
- •9. Adequate renal and hepatic function (creatinine and bilirubin = 1.5 X IULN;
- •AST and ALT = 2.5 X IULN [= 5.0 x IULN if due to liver metastases]).
- •10. At least 4 weeks beyond any major surgery or radiotherapy, 2 weeks beyond chemotherapy or other experimental treatments, and with any clinically significant related acute toxicities recovered at study entry to Grade 1 by NCI CTCAE v4.0.
- •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 440
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patients of childbearing potential sexually active but unwilling to use double barrier” methods of birth control including male use of a condom with female use of a diaphragm, intrauterine device (IUD), or contraceptive sponge during the study until at least 4 weeks after the last dose of active study drug.
- •2. History of allergy or hypersensitivity or severe toxicity to any of the study drugs or their incipients
- •3. Known metastatic disease to the central nervous system, unless previously treated and well-controlled for at least 3 months [defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart]
- •4. Presence of bulky disease (defined as any single mass > 10 cm in greatest dimension).
- •5. Patients with Grade = 3 nausea or vomiting, and/or signs of intestinal obstruction.
- •6. Rapid deterioration during screening prior to randomization, i.e. 10% decrease in KPS, 20% decrease in serum albumin levels, unstable pain symptoms requiring modifications in analgesic management, development of jaundice or symptomatic ascites.
- •Prior external beam irradiation to a field that includes more than 30% of the red
- •bone marrow.
- •8. Patients with non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, or other non-invasive malignancy are not excluded, but patients with other prior malignancies must have had at least a 2-year disease-free interval.
- •9. Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
- •10. Patients with:
- •a. Active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months.
- •b. Cardiac arrhythmia (other than stable atrial fibrillation) requiring antiarrhythmia therapy, NYHA Class II-IV disease, or prolonged QT/QTc interval.
- •c. Other clinically significant cardiac disease, unless baseline MUGA/2DECHO performed and LVEF is within institutional limits.
- •11. Moderate-to-severe (Grade = 3) respiratory illness present within 6 months.
- •12. Infection requiring intravenous antibiotic use within 1 week.
- •13. Other concurrent medical or psychiatric conditions that, in the Investigator’s
- •opinion, may be likely to confound study interpretation, prevent completion of
- •study procedures and follow-up examinations, or may cause undue risk to the patient
研究者
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