EUCTR2016-001755-45-BE进行中（未招募）1 期
FOCUS: A Multicenter, Multinational, Double-blind, 2-Arm, Randomized, Phase 2/3, Study of Physician’s Choice Chemotherapy (PCC) (Weekly Paclitaxel or Pegylated Liposomal Doxorubicin [PLD]) Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo for Subjects with Platinum-Resistant, Recurrent, Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer - FOCUS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 436
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. Signed informed consent form (ICF).
- •2. Age = 18 years (age = 19 years if required by local regulatory authorities).
- •3. ECOG performance status of 0-1.
- •4. Histologically or cytologically-confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer in recurrent stage.
- •5. Platinum-resistant ovarian cancers defined as progression within 6 months of receiving last platinum-based therapy.
- •6. Received = 1 prior platinum-based regimen.
- •7. Measurable disease according to RECIST 1.1.
- •8. LVEF greater than or equal to at least 45% at baseline assessment if subject is receiving pegylated liposomal doxorubicin and/or anthracycline as a concomitant medication.
- •9. No evidence of active (progressing) brain metastasis (treated brain metastasis allowed with a post-treatment MRI or CT of brain showing no active (progressing) brain metastasis). Treatment of brain metastasis may include surgery, radiosurgery (LINAC, gamma knife) or whole brain irradiation. Surgery for brain metastasis must be > 8 weeks from study entry.
- •10. Hemoglobin > 9 g/dL without transfusions or growth factors.
- •11. Adequate bone marrow function in the investigator’s opinion.
- •12. Adequate hepatic function defined by the following:
- •- Total bilirubin < 2 x ULN;
- •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 X ULN for the referenced lab (< 5 X ULN for subjects with liver metastases).
- •13. Adequate renal function defined by the following:
- •- Serum creatinine < 2 X ULN for the referenced lab.
- •14. Subjects of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing a highly effective form of contraception.
- •15. At least 2 weeks since prior radiotherapy and has recovered from any Grade 3 toxicities.
- •16. Life expectancy = 12 weeks.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 136
排除标准
- •1. Subjects who have received prior CA4P therapy.
- •2. Previously having failed treatment with bevacizumab combined with the intended physician's choice chemotherapy (PCC). Investigators should not select a bevacizumab + PCC combination for the FOCUS trial if the patient has previously failed that same regimen, however they may select a new PCC regimen to combine with bevacizumab.
- •3. Previous treatment with greater than two previous chemotherapy treatment regimens.
- •4. Untreated brain metastasis or leptomeningeal brain metastasis.
- •5. Solid organ or bone marrow transplant.
- •6. Primary platinum-refractory disease (defined as progression during
- •or within 1 month of completing patients first platinum-containing
- •7. > Grade 2 peripheral neuropathy.
- •8. Current thrombotic or hemorrhagic disorder/event or history of prior event within 6 months of start of screening.
- •9. History of prior cerebrovascular event (including transient ischemic attack) within 6 months of start of screening.
- •10. Recent history (within 6 months of start of screening) of angina pectoris, myocardial infarction (including non-Q wave MI), or NYHA Class III and IV congestive heart failure.
- •11. History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm), heart block (excluding 1st degree block, benign PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG.
- •12. Known uncontrolled HIV infection.
- •13. Uncontrolled, clinically significant active infection.
- •14. Serious non-healing wound, ulcer or bone fracture.
- •15. Subjects with known hypersensitivity to any of the components of CA4P, paclitaxel, pegylated liposomal doxorubicin or bevacizumab.
- •16. Subjects who are currently or planning on receiving concurrent investigational therapy or who have received investigational therapy for any indication within 30 days of the first scheduled day of dosing.
- •17. Subjects with any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subjects ability to provide informed consent, cooperate and participate in the study, or interfere with the interpretation of the study results.
- •18. Subjects with other invasive malignancies, with the exception of non-melanoma skin cancer, or with previous cancer treatment that contraindicates this protocol therapy.
- •19. Prior radiation therapy to the pelvis or abdomen within 4 weeks of entry into the study.
- •20. History of fistula, gastrointestinal (GI) perforation or intra-abdominal abscess, or invasive
- •disease/metastases of the bowel which may increase the risk of GI perforation with
- •bevacizumab treatment.
- •21. Uncontrolled hypertension:
- •- Sustained BP greater than 150 SBP / 100 DBP.
- •22. Uncontrolled elevated proteinuria levels in the investigator's opinion.
- •23. Corrected QT interval ([QTc] Fridericia) > 480 ms.
- •24. Significant vascular disease or recent peripheral arterial thrombosis.
- •25. Subjects with active bleeding or pathologic conditions that carry high risk of bleeding.
- •26. Subjects who are pregnant or lactating.
研究者
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