EUCTR2021-000293-28-IT进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB S6 500 in Combination with Paclitaxel in Patients with Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC) - AXLerate-OC
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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. Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
- •2. Aged 18 years or older.
- •3. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1.
- •4. Ability to understand the nature of this clinical study and willingness to give written informed consent, comply with scheduled visits, the treatment plan, laboratory tests, and follow up visits.
- •5. Platinum resistant disease (defined as progression within = 6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy). Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance.
- •6. Available archived tumor tissue (a paraffin-embedded tissue block with sufficient tumor tissue for biomarker testing or unstained slides with sufficient tumor tissue may be substituted) or if archived tissue is not available, a fresh tumor biopsy is required.
- •7. Radiologic imaging with a computerized tomography (CT) scan or magnetic resonance imaging (MRI) (if cannot tolerate a CT scan) within 21 days of randomization. (If a site can document the CT
- •performed as part of the positron emission tomography [PET]-CT is of identical diagnostic quality to a diagnostic CT [with IV and oral contrast], then the CT portion of a PET-CT can be used.)
- •8. Received at least 1 but not more than 4 prior therapy regimens since ovarian cancer diagnosis.
- •a. Maintenance therapy OR hormonal therapies should not be counted as a separate therapy.
- •b. Patients who have not received prior bevacizumab must be deemed medically inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been unable to receive
- •bevacizumab due to lack of access.
- •9. Ovarian cancer that is measurable according to RECIST v1.1.
- •10. Normal gastrointestinal (GI) function.
- •11. Life expectancy > 3 months.
- •12. Negative serum pregnancy test within 7 days prior to randomization for females of childbearing potential (premenopausal and not surgically sterilized).
- •13. Adequate bone marrow function:
- •a. Absolute neutrophil count = 1500/µL
- •b. Platelet count = 100,000/ µL
- •c. Hemoglobin = 9.0 g/dL
- •14. Adequate hepatic function:
- •a. Total bilirubin = 1.5 × upper limit of normal (ULN)
- •b. Aspartate aminotransferase (AST) = 3.0 × ULN*
- •c. Alanine aminotransferase (ALT) = 3.0 × ULN*
- •*Unless liver metastases are present, in which case AST/ALT must be
- •15. Adequate renal function as determined by calculated or measured creatinine clearance = 30 mL/min (using Cockcroft-Gault equation).
- •16. International normalized ratio (INR) = 1.5 and activated partial thromboplastin time (aPTT) = 1.5 x ULN for subjects not on anticoagulation treatment. If subjects are on anticoagulation treatment,
- •the corresponding laboratory values should be in therapeutic range for the respective agent.
- •17. Full recovery from all recent surgery on date of randomization; at least 1 week must have elapsed from the time of a minor surgery (port placement at any time is acceptable); from the date of randomization at least 21 days must have elapsed from the time of a major surgery. Must
- •have fully recovered from all surgery-related toxicities to Grade 1 or less.
- •18. At least 28 days between termination of prior anticancer or hormonal therapy and first administration of AVB-S6-500.
- •19. Full recovery from all treatment-relate
排除标准
- •1. Tumors in the breast or bone.
- •2. Untreated central nervous system (CNS) metastases (surgery and/or radiotherapy). Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on
- •> 10 mg/day prednisone or equivalent OR have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
- •3. Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen).
- •4. Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
- •5. Received prior therapy with PAC in the platinum-resistant recurrent setting.
- •6. Clinically significant cardiac disease history including the following:
- •a. cardiac arrhythmia uncontrolled on medication
- •b. unstable angina or clinically and/or electrocardiographically documented myocardial infarction within 6 months before randomization
- •c. clinically significant valvular disease
- •d. uncontrolled congestive heart failure
- •d. QT (QTc) prolongation > 470 msec
- •e. clinically significant pericardial effusion.
- •7. History of a prior malignancy that was active (not indolent) within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer,
- •superficial bladder cancer, endometrial stage 1 cancer, or carcinoma in situ of the cervix or breast.
- •8. History of or present CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g., uncontrolled seizures).
- •9. Nonhealing wound, ulcer, or bone fracture.
- •10. Evidence of clinically significant third spacing (e.g., pleural effusions, ascites, anasarca, etc.) that requires therapeutic intervention within 28 days prior to first dose of AVB-S6-500/placebo.
- •11. Serious active infection requiring IV antibiotics and/or hospitalization within 7 days of randomization.
- •12. Known severe hypersensitivity to any of the study drugs or excipients, including history of allergic, anaphylactic, or other severe hypersensitivity reactions to fusion proteins, products containing
- •Cremophor EL (e.g., cyclosporin for injection concentrate and teniposide for injection concentrate), or known hypersensitivity or allergy to Chinese hamster ovary cell products.
- •13. History of or evidence of any other medical conditions, psychiatric condition, physical examination or laboratory findings that may interfere with the subject’s participation for the full duration of the
- •Study Treatment, affect subject compliance, place the subject at high risk from treatment-related complications, confound the results of the study, or is not in the best interest of the subject to participate.
- •14. Known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, or any other known active viral illness such as coronavirus disease 2019 (COVID-19).
- •15. Patient currently breastfeeding or intending to become pregnant on study or within 6 months following discontinuation of Study Treatment.
- •16. Ever participated in a study with AVB-S6-500.
研究者
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