EUCTR2013-001426-26-ES进行中（未招募）不适用
A phase 2, randomized, open label study to evaluate the efficacy, safety, pharmacodynamics, pharmacokinetics of the anti-ALK-1 MAB PF-03446962 in combination with best supportive care vs. best supportive care alone in adult patients with advanced hepatocellular carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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. Diagnosis of locally advanced or metastatic HCC, obtained by histology/cytology (on a prior tumor biopsy) or by imaging (acceptable imaging modalities include triphasic contrast-enhanced helical CT, triphasic dynamic contrast-enhanced MRI and contrast-enhanced ultrasonography); all patients must provide one archival tumor specimen (if collected at the time of primary diagnosis and still available).
- •2. HCC not amenable to local therapy.
- •3. Documented progression on or after treatment with sorafenib. Patients who withdrew from sorafenib due to intolerance are eligible provided that they had disease progression and did not receive any anti-cancer therapy after the last sorafenib dose. Sorafenib failure must be confirmed by the Investigator upon review of appropriate imaging documentation. Imaging documentation of sorafenib failure must be retained at the site by the Investigator for potential retrospective independent central review; before randomization, all patients must provide a de novo tumor block obtained after disease progression on sorafenib (pre-randomization de novo biopsy). Inability to obtain this biopsy will make the patient ineligible for the study
- •4. Measurable or non-measurable disease according to RECIST v. 1.1.
- •5. Child-Pugh Class A disease (see Appendix 1). Score for hepatic encephalopathy must be 1; ascites score must be ? 2.
- •6. At least 2 weeks since completion of prior radiotherapy, or surgical procedure (4 weeks for major surgery).
- •7. All prior treatment-related toxicities must have resolved to baseline severity or CTCAE Grade ?1 except for alopecia or other AEs not constituting a safety risk for the patients by investigator?s judgement.
- •8. Age ?18 years (or ?20 years for Japanese patients).
- •9. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 or 1.
- •10. Adequate bone marrow function (including ANC ?1,500/mm3; Platelets ? 75,000/mm3; Hemoglobin ?9 g/dL).
- •11. Adequate renal function (including serum creatinine ?1.5 x ULN, or creatinine clearance ?60 ml/min as per institution standard).
- •12. INR <1.7 or prothrombin time (PT) prolongation < 4 seconds* above ULN.
- •13. Adequate liver function (including AST/ALT ?5.0 x ULN; total serum bilirubin ?2 mg/dL*; and serum albumin ? 2.8 g/d**) [See Appendix 1 protocol: Child-Pugh Score ?1* or ?2**].
- •14. Prior liver transplantation is permitted; immunosuppressive agents in transplanted patients are also allowed.
- •15. Male and female patients of childbearing potential, must agree to use a highly effective method of contraception throughout the study and for 6 months after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
- •16. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study.
- •17. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Prior systemic treatment for advanced HCC other than 1st-line sorafenib (single agent or in combination).
- •2. Prior local therapy (such as hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection or cryoablation) within 2 weeks of starting the study treatment.
- •3. Presence of main portal vein invasion by HCC (invasion to 1st or 2nd branch of portal vein is acceptable).
- •4. Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are radiographically and neurologically stable.
- •5. Clinically significant bleeding disorders, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 3 months; or untreated high risk esophageal varices in patients with known portal hypertension.
- •6. History of Osler-Weber-Rendu syndrome or Hereditary Hemorrhagic Telangiectasia.
- •7. Known active and clinically significant bacterial, fungal or viral infection (other than hepatitis B (HBV), hepatitis C (HCV)), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •8. Any one of the following currently or in the previous 6 months: myocardial infarction, congenital long QT syndrome, torsades de points, clinically significant ventricular arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF NY Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms. Ongoing cardiac dysrrhythmias of CTCAE Grade ?2, atrial fibrillation of any grade, or QTc interval >480 msec (unless considered not clinically significant) at screening are exclusionary.
- •9. Pregnant females; breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 6 month after last dose of investigational product.
- •10. Participation in other studies involving investigational drugs (Phases 1-4) within 1 month before the current study begins and/or during study participation.
- •11. Other severe acute or chronic medical or psychiatric condition (including recent [within the past year] or active suicidal ideation or behavior) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •12. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees directly involved in the conduct of the trial.
- •13. History of any other malignancy in the previous 3 years (except for local cancers resected with curative intent
研究者
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