EUCTR2007-004102-27-HU进行中（未招募）不适用
A Randomized, Double Blind, Placebo Controlled, Phase II Study Evaluating the Efficacy and Safety of RP101 in Combination with Gemcitabine Administered as First-Line Treatment to Subjects with Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 153
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. Male or female subjects 19 years of age or older
- •2. Subjects with a histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas that is unresectable, locally advanced or metastatic
- •3. ECOG performance status 0 or 1
- •4. Life expectancy of at least 3 months
- •5. Documentation of all sites of pancreatic cancer disease withing 28 days prior to treatment start by CT or spiral CT or MRI scan of chest, abdomen, brain (only if clinical suspicion of metastasis), and other scans necessary. Negative scans performed within 35 days of randomization do not need to be repeated
- •6. Adequate hematological, renal, and hepatic function within 14 days prior to treatment start defined as follows:
- •-Hemoglobin (HGB) = 9.0 gm/dL (prior transfusion and/or support with erythropoietin-based products is acceptable)
- •-Absolute granulocyte count = 1.5 x 109/L (1500 cells/mm3) unsupported for 1 week by growth factors
- •-Platelet count = 100 x 109/L (100,000/mm3) non-platelet transfusion dependent
- •-Serum creatinine < 1.5 times the upper limit of normal
- •-Total bilirubin < 2.0 times the upper limit of normal
- •-ALT (SGPT) < 2.0 times the upper limit of normal and/or AST (SGOT) < 2.0 times the upper limit of normal. If clearly attributable to liver metastasis, ALT and/or AST < 5.0 times the upper limit of normal is permitted
- •7. Capability of understanding the objectives of the study and giving written informed consent
- •8. Willingness and ability to comply with the study protocol for the duration of the study
- •9. Capability to have sufficient oral caloric and fluid intake and to take oral study medications
- •10. If subject is female and of child bearing potential she must have a negative ß-HCG urine test within 72 hours prior to receiving treatment. Being of child bearing potential is defined as any female subject who does not meet at least one of the following criteria: a) has undergone bilateral salpingo-oophorectomy and/or hysterectomy; b) is greater than age 50 years and has not had a menstrual period for at least 24 months
- •11. All potentially fertile subjects, both female and male, must practice a medically approved method of contraception or agree to abstinence for the duration of participation in the active treatment phase of the study and for a period of 4 weeks after the last administration of either study drug
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior history of other malignant tumors, except non-melanoma skin cancer or in situ cervical carcinoma curatively excised. Subject may be included if disease-free of cancers other than pancreatic cancer for 5 years
- •2. Major surgery within 2 weeks prior to treatment start
- •3. Any prior cytotoxic chemotherapy other than 5-FU (+/- folinic acid) or gemcitabine given concurrently with radiation treatment as a radiosensitizer”. 5-FU must not have been given within 21 days prior to randomization.
- •4. Radiation treatment within 4 weeks of treatment start. Prior radiation treatment for management of local disease is allowed, provided that local disease progression or progression by new measurable metastasis outside of the radiation portal is documented by imaging procedure, all toxicities resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to treatment start.
- •5. Uncontrolled cardiac atrial or ventricular arrhythmias (New York Heart Association (NYHA) congestive heart failure = class 2; uncontrolled hypertension; pulmonary embolism or cerebrovascular accident (CVA) within 6 months
- •6. Neurologic: symptomatic motor or sensory neurotoxicity grade = 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC)
- •7. Central nervous system metastasis
- •8. Psychiatric disabilities, seizures or central nervous system disorders thought to be clinically significant in the opinion of the Investigator that could interfere with informed consent or compliance with the protocol
- •9. Active bleeding Grade = 2 of NCI-CTC
- •10. Serious (Grade 3-4 of NCI-CTC) active infections at time of treatment start
- •11. Subjects with known allergies or intolerance to RP101 or similar compounds
- •12. Subjects with known allergies or intolerance to gemcitabine
- •13. Participation in any investigational drug study with investigational drug exposure within 4 weeks prior to treatment start
- •14. Pregnant or breast feeding women
- •15. Gastrointestinal (GI) tract disease resulting in an inability to take oral medication, such as uncontrolled inflammatory GI diseases (eg, Crohn’s disease, ulcerative colitis) or postsurgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency or requires IV hyperalimentation (however, use of pancreatic enzyme supplementation is allowed provided that the above criteria are not met) resulting in an inability to take oral medication
- •16. Known to be seropositive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection or acute or chronic hepatitis
- •17. Any condition which in the judgment of the Investigator would place the subject at undue risk or interfere with the results of the study (eg, low medical risks because of non-malignant organ or systemic disease, or secondary effects of cancer)
- •18. Uncontrolled cancer pain.
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