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临床试验/EUCTR2015-004060-11-BG
EUCTR2015-004060-11-BG进行中（未招募）1 期

FORWARD 1: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women with Folate Receptor a-positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

ImmunoGen, Inc.0 个研究点目标入组 333 人开始时间: 2018年3月13日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
333
研究概览入排标准研究者记录与标识符相似试验

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
Female

入选标准

  • •1. Patients must have one of the following pathologically documented, definitively diagnosed tumor types:
  • •a. Advanced EOC
  • •b. Primary peritoneal cancer
  • •c. Fallopian tube cancer
  • •2. Patients must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy. This should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.
  • •3. Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
  • •4. Patients must have received at least one but no more than three prior systemic lines of anti-cancer therapy and for whom single agent chemotherapy is appropriate as the next line of treatment.
  • •a. Adjuvant±Neoadjuvant will be considered as one line of therapy
  • •b. Maintenance therapy (example: bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (i.e., not counted independently)
  • •5. Patients must be willing to provide an archival tumor tissue, or fresh biopsy collected using a non-significant risk procedure. Patients who do not have archival tissue and for whom the only sites of disease would require biopsy procedure considered to be of significant risk must not be enrolled in the study. These significant risk procedures include (but are not limited to) biopsies of the brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach or bowel.
  • •6. Patients must have confirmation of FRa positivity by Ventana IHC test (= 50% of tumor staining at =2+ intensity) in archival or fresh biopsy tumor sample. If the archival tumor tissue does not meet FRa criteria, a fresh biopsy tumor sample may be submitted and if positive, it may be used to meet this criterion.
  • •7. Female patients = 18 years of age
  • •8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • •9. Time from prior therapy:
  • •a. Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter
  • •b. Focal radiation completed at least two weeks, prior to starting study drug
  • •10. Patients must have stabilized or recovered (Grade 1 or baseline) from all therapy-related toxicities.
  • •11. Major surgery (not including placement of vascular access device or tumor biopsies) must be completed four weeks prior to Day 1. Patients must have recovered or stabilized from the side effects prior to study treatment
  • •12. Patients must have adequate hematologic, liver and kidney function as defined by the following parameters:
  • •a. Absolute neutrophil count (ANC) = 1.5 x 109/L (1,500/µL)
  • •b.Platelet count = 100 x 109/L (100,000/µL); no transfusion within previous 10 days
  • •c. Hemoglobin = 9.0 g/dL
  • •d. Serum creatinine = 1.5 x upper limit of normal (ULN) or 24-hour creatinine clearance of = 60 mL/minute
  • •e. AST = 3.0 x ULN; ALT = 3.0 x ULN
  • •f. Serum bilirubin = 1.5 x ULN (Patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN)
  • •g. Serum albumin = 2 g/dL
  • •13. Patients must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements.
  • •14. Women of childbearing potential (WCBP) are defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months)

排除标准

  • •1. Male patients
  • •2. Patients with clear cell, mucinous histology, mixed histology with mucinous component, sarcoma, sarcomatous component, or low grade ovarian cancer
  • •3. Patients with primary platinum-refractory disease as defined by those who progressed during or within four weeks of completion of first platinum-based chemotherapy).
  • •4. Patients who have received prior wide-field radiotherapy affecting at least 20% of the bone marrow
  • •5. Patients with uncontrolled bleeding disorders or inadequate coagulation parameters:
  • •a. Activated partial thromboplastin time (aPTT) )>1.5 x ULN, unless related to lupus anticoagulant. Patients receiving unfractionated heparin must have aPTT between 1.5 and 2.5 x ULN or within a range determined by their physician.
  • •b. International normalized ratio (INR)>1.5. Patients receiving warfarin must have an INR between 2.0 and 3.0 or within a range determined by their physician
  • •6. Patients with > Grade 1 peripheral neuropathy
  • •7. Active or chronic corneal disorders such as Sjogren’s syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, active ocular conditions requiring on-going treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.
  • •8. Serious concurrent illness or clinically-relevant active infection, including, but not limited to the following:
  • •a. Known active hepatitis B or C whether or not on active antiviral therapy
  • •b. Known Human Immunodeficiency Virus (HIV) infection
  • •c. Varicella-zoster virus (shingles)
  • •d. Cytomegalovirus infection
  • •e. Any other known concurrent infectious disease, requiring IV antibiotics within 2 weeks of starting study treatment
  • •9. Clinically-significant cardiac disease including any one of the following:
  • •a. Recent myocardial infarction (= 6 months prior to day 1)
  • •b. Unstable angina pectoris
  • •c. Uncontrolled congestive heart failure (New York Heart Association > class II), uncontrolled hypertension (= CTCAE v4.03 Grade 3)
  • •d. Uncontrolled hypertension (= CTCAE v4.03 Grade 3)
  • •e. If the choice of chemotherapy agent is PLD for patients randomized to the IC chemotherapy arm, LVEF (measured by Echocardiography (ECHO) or Multigated Acquisition (MUGA) scan) that is below the institutional limit of normal
  • •f. Clinically-significant vascular disease (e.g. aortic aneurysm, or dissecting aneurysm)
  • •g. Severe aortic stenosis
  • •h. Clinically significant peripheral vascular disease, or = Grade 3 cardiac toxicity following prior chemotherapy
  • •I. Corrected QT (QTc) >470 msec using on-screening ECG
  • •10. History of neurological condition, or concurrent neurological condition that would confound assessment of treatment-emergent neuropathy
  • •11. History of multiple sclerosis or other demyelinating disease and/or Eaton-Lambert syndrome (para-neoplastic syndrome)
  • •12. History of hemorrhagic or ischemic stroke within the last 6 months
  • •13. History of cirrhotic liver disease
  • •14. Previous clinical diagnosis of non-infectious interstitial lung disease, including non-infectious pneumonitis
  • •15. Required use of folate –containing supplements (e.g. folate deficiency)
  • •16. Prior hypersensitivity to monoclonal antibodies
  • •17. Women who are pregnant or lactating
  • •18. Patients with known hypersensitivity to any of the SOC chemotherapy agents incl

研究者

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