EUCTR2011-003753-26-DE进行中（未招募）不适用
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined with gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 244
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. Willingness to sign the subject informed consent
- •2. Initial diagnosis of metastatic pancreatic cancer must have occurred = 6 weeks
- •prior to the completion of screening
- •3. The presence of measurable metastatic pancreatic cancer documented
- •by contrast enhanced CT (or MRI) scan in addition to 1 of the
- •a) Histological diagnosis of pancreatic adenocarcinoma confirmed by
- •pathologist OR
- •b) Pathologist confirmed histological/cytological diagnosis of
- •adenocarcinoma consistent with pancreatic origin in conjunction with
- •(1) The presence of a mass in the pancreas OR
- •(2) A history of resected pancreatic carcinoma
- •4. Measurable disease per RECIST (ver. 1.1), defined with all of
- •following criteria:
- •a) Lesions accurately measured in at least 1 dimension
- •b) The longest diameter in the plane of measurement is to be recorded
- •c) A minimum size of 10 mm if CT slice thickness = 5 mm; if
- •thickness is > 5 mm then the minimum size of measurable lesions
- •should be twice slice thickness
- •5. Male or female =18 years of age
- •6. ECOG Performance Status of 0 or 1
- •7. Women of childbearing potential must agree to use 1 medically
- •approved (i.e., mechanical or pharmacological) contraceptive measure
- •and have their partners agree to an additional barrier method of
- •contraception for the duration of the study and for 90 days after the last
- •administration of study drug
- •8. Male subjects must agree to use protocol-recommended methods of
- •contraception during heterosexual intercourse and avoid sperm donation
- •for the duration of this study and for 6 months after the last dose of
- •gemcitabine.
- •9. Adequate organ function defined as follows:
- •a. Hematological: Platelets =100 x 109/L; Hemoglobin =9.0 g/dL;
- •Absolute Neutrophil
- •Count (ANC) =1.5 x 109/L
- •b. Hepatic: AST/ALT =2.5 x ULN (if liver metastases are present, =5 x
- •ULN); Total or conjugated bilirubin =1.5 x ULN
- •c. Renal: Serum Creatinine =1.5 x ULN OR creatinine clearance = 60
- •ml/minute as calculated by the Cockroft-Gault method
- •10. Coagulation: International Normalized Ratio (INR) = 1.6 (unless
- •receiving anticoagulation therapy). Patients on full-dose anticoagulation
- •must be on a stable dose (minimum duration 14 days) of oral
- •anticoagulant or low molecular weight heparin. If receiving warfarin, the
- •patient must have an INR = 3.0 and no active bleeding (ie, no bleeding
- •within 14 days prior to first dose of study therapy).
- •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 234
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas or clinical significant laboratory finding that in the investigator’s judgment would pose a risk to subject
- •safety, interfere with study procedures, or prevent completion of the study
- •2. A diagnosis of pancreatic islet neoplasms
- •3. Subject has undergone major surgery other than diagnosis surgery within 4 weeks of enrollment (Part A)/ randomization (Part B)
- •4. Subjects for whom combination treatment with erlotinib and gemcitabine was planned
- •5. Subjects with biliary obstruction requiring external drainage
- •6. Pregnant or lactating
- •7. Known or suspected cerebral metastases
- •8. History or presence of any form of cancer, other than pancreatic
- •cancer, within the 3 years prior to enrollment, with the exception of
- •excised basal cell or squamous cell carcinoma of the skin, stage 0 or 1
- •melanoma, or cervical carcinoma in situ or breast carcinoma in situ that
- •has been excised or resected completely and is without evidence of local
- •recurrence or metastasis.
- •9. Unstable cardiovascular function including but not limited to: myocardial infarction within the last 6 months of screening, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- •10. Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at Screening.
- •11. Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
- •12. Known HIV infection
- •13. Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ngoing signs/symptoms related to the infection and without improvement) despite appropriate
- •antibiotics use
- •14. Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed
- •15. Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study Day 1 of Cycle 1 or within 5 times the half-life of the investigational drug in the other clinical
- •study, if known, whichever is shorter
- •16. Known hypersensitivity to the study investigational medicinal products or formulation excipients
研究者
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The purpose of this study is to test the effectiveness and safety of GS-6624 at different dose levels when it is given with Gemcitabine. We want to find out what effects, good and/or bad, GS-6624 has on you and your metastatic pancreatic adenocarcinoma when it is given with Gemcitabine. Gemcitabine is approved by the FDA for metastatic pancreatic adenocarcinoma.Metastatic Pancreatic AdenocarcinomaMedDRA version: 15.1Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864EUCTR2011-003753-26-PLGilead Sciences, Inc.244