EUCTR2021-001933-38-ES进行中（未招募）1 期
A Phase 3 Multicenter, Open-Label, Randomized Study of Navicixizumab Plus Paclitaxel and Navicixizumab Monotherapy in Comparison to Paclitaxel Monotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer - REVELARE
适应症
相关药物
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. Patient provides signed informed consent to participate in the study prior to undergoing any study procedures, including screening procedures.
- •2. Patient is =18 years old or age of majority in the country in which they reside, whichever is higher.
- •3. Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer consisting of one of the following histological subtypes:
- •- adenocarcinoma not otherwise specified
- •- clear cell adenocarcinoma
- •- endometrioid adenocarcinoma
- •- malignant Brenner's tumor
- •- mixed epithelial carcinoma
- •- malignant mixed Mullerian
- •- serous adenocarcinoma
- •- transitional cell carcinoma
- •- undifferentiated carcinoma
- •4. Patients must have received =2 and not more than 5 prior therapies, including at least 1 line of therapy containing bevacizumab (or biosimilar).
- •- Adjuvant/neoadjuvant therapy is counted as only 1 regimen in the absence of intervening progression.
- •- Maintenance therapy (e.g., bevacizumab or a PARP inhibitor will be considered part of the preceding line of therapy [i.e., not counted independently]).
- •- Therapy changed due to toxicity in the absence of progression will be considered part of the same line (i.e., not counted independently).
- •- Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance.
- •- Patients with known BRCA-1 or -2 mutation should have received a prior PARP inhibitor.
- •5. Patients must be considered platinum-resistant, defined as progression within 6 months from completion of a platinum-containing therapy. The date should be calculated from the last administered dose of platinum-containing therapy.
- •6. Patient must be considered appropriate for treatment with weekly paclitaxel monotherapy as the next line of therapy.
- •7. Patient must be willing and able to provide an FFPE archival or core tumor sample for determination of biomarker status on the Xerna™ TME Panel biomarker assay (positive or negative)prior to study treatment.
- •8. Determination of B+ or B- status on the Xerna™ TME Panel biomarker assay.
- •9. Presence of at least one measurable lesion, as defined by RECIST v1.1. Previously irradiated lesions can be considered as measurable if disease progression has been unequivocally demonstrated at that lesion since radiation.
- •10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- •11. Adequate organ function defined as:
- •- Absolute neutrophil count (ANC) =1.5 x 109/L.
- •- Hemoglobin =9 g/dL. The patient may have been transfused to meet eligibility criteria; however, hemoglobin should remain stable and =9 g/dL for at least 1 week prior to first dose of study therapy.
- •- Platelet count =100 x 109/L.
- •- Total serum bilirubin =1.5 x institutional upper limit of normal (ULN). Patients with known Gilbert syndrome who have serum bilirubin level =3 x ULN may be enrolled upon discussion with the medical monitor.
- •- Aspartate aminotransferase and alanine aminotransferase =3.0 x ULN or =5 x ULN (based on institutional limits) if there are documented metastases in the liver.
- •- Serum creatinine =1.5 x ULN for the reference laboratory or a calculated creatinine clearance of =30 mL/min by the Cockcroft-Gault equation.
- •- International normalized ratio and activated partial thromboplastin time (aPTT) within 1.5 x the institutional ULN. If a patient is receiving anticoagulant therapy, then prothrombin time/aPTT should be within therapeutic range of intended use.
- •12. Women of childbearing potential must have a negative serum or urine pregna
排除标准
- •1. Non-epithelial ovarian carcinoma.
- •2. Ovarian tumors with low malignant potential (i.e., borderline tumors).
- •3. Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen).
- •4. Patient has received an anti-angiogenic product other than bevacizumab or biosimilar.
- •5. Patient has any of the following conditions related to cardiac function:
- •- Symptomatic congestive heart failure (New York Heart Association Class II to IV; Appendix 2).
- •- History of myocardial infarction, cerebral vascular accident, or transient ischemic attacks within 6 months prior to C1D1.
- •- History of cardiac ischemia or heart failure within 6 months prior to C1D1.
- •- Baseline B-type natriuretic peptide (BNP) value >100 pg/mL or N-terminal-proBNP (NT-proBNP)value of > 125 pg/mL.
- •- LVEF <50%.
- •- Peak tricuspid velocity >3.0 m/s on Doppler ECHO.
- •- Clinically significant ECG abnormality, as assessed by the investigator.
- •6. Blood pressure (BP) >140/90 mmHg. Patients taking antihypertensive medications must be taking =2 medications to obtain BP control of =140/90 mmHg.
- •Note: Fixed-dose combination treatments should be considered 2 medications.
- •7. Pregnant or lactating women.
- •8. Active/unstable brain metastases including leptomeningeal disease.
- •9. Known additional malignancy that was progressing or had required active treatment within 2 years prior to the first dose of study medication. Exceptions include malignancies with a negligible risk of metastasis or death, including basal cell basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ).
- •10. History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, GI perforation, or intra-abdominal abscess. Evidence of recto sigmoid involvement by pelvic examination or bowel involvement on computed tomography (CT) scan or clinical symptoms of bowel obstruction.
- •11. Pre-existing Grade =2 peripheral neuropathy, according to the CTCAE v5.0.
- •12. Active infection requiring IV systemic therapy.
- •13. Known hypersensitivity to any components of monoclonal antibodies, including navicixizumab or any of its excipients that, in the opinion of the investigator, suggests a high risk for a severe hypersensitivity reaction while on treatment.
- •14. Known clinically significant bleeding disorder.
- •15. Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for >14 days prior to C1D1.
- •Note: Prophylactic doses of anticoagulants, low-dose aspirin, and/or non-steroidal anti-inflammatory agents are allowed.
- •16. Hemoptysis >2.5 mL within 8 weeks prior to C1D1 or serious bleeding from another site within this time frame.
- •17. Major surgical procedure, or significant traumatic injury within 28 days prior to C1D1, or anticipation of need for major surgical procedure during the study.
- •Note: Placement of a vascular access device will not be considered major surgery.
- •18. Patients with an uncontrolled seizure disorder or active neurologic disease.
- •19. Patients with a cardiac aneurysm.
- •20. Known psychiatric, substance abuse disorder, or geographical travel limitations that would interfere with patient’s ability to cooperate with the requirements of the study.
- •21. History or current evidence of any condition, therapy, or laboratory abnormality that may confound the results o
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