EUCTR2013-001472-38-ES进行中（未招募）1 期
PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 - PiSARRO
Aprea AB0 个研究点目标入组 180 人开始时间: 2015年11月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
入选标准
- •1. Archived sections from the original FFPE sample reviewed by a gynecological pathologist confirming High Grade Serous Ovarian Cancer, and positive nuclear IHC staining for p53 assessed according to local laboratory standard. Cases that do not show nuclear p53 staining will not be included.
- •2. Disease Progression between six and twenty-four (6-24) months after a first or second platinum based regimen.
- •3. At least a single (RECIST v1.1) measurable lesion. Phase II patients only.
- •4. A tumour that is accessible to repeat biopsies. Phase I highly desirable. Phase II mandatory.
- •5. Adequate organ function prior to registration:
- •Bone Marrow Reserve:
- •? Absolute neutrophil count (ANC) ? 1.5 x10^9/L,
- •? Platelets ? 100 x10^9/L,
- •? Hemoglobin ? 9 g/dL.
- •? Total bilirubin level < 1.5 x ULN,
- •? ALT, AST, GGT, and alkaline phosphatase levels < 2.5 x ULN.
- •? Calculated creatinine clearance > 60ml/min.
- •6. Toxicities from previous cancer therapies must have recovered to grade 1 (defined by CTCAE 4.0). Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis by the Principal Investigator.
- •7. If of childbearing potential, negative pre-treatment serum pregnancy test.
- •8. If of childbearing potential, willing to use an effective form of contraception such as hormonal birth control, intrauterine device or double barrier method during chemotherapy treatment and for at least six months thereafter.
- •9. ECOG performance status of 0 to 1.
- •10. ? 18 years of age.
- •11. Signed, informed consent.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1. Prior exposure to cumulative doses of doxorubicin >400 mg/m2 or epirubicin >720 mg/m2.
- •2. Confirmed cardiac history of any of the following:
- •Myocardial infarct within six months prior to registration,
- •New York Heart Association Class II or worse heart failure,
- •A history of familial long QT syndrome,
- •Clinically significant pericardial disease,
- •Electrocardiographic evidence of acute ischemia,
- •Arrhythmias not controlled by medications,
- •Serious ventricular arrhythmia (VT>130 bpm and > 5 beats, QTc ? 480 msec calculated from a single ECG reading or a mean of 3 ECG readings using Friderica?s correction (QTcF = QT/RR0.33) or bradycardia (<45bpm)
- •Left ventricular ejection fraction (LVEF) < the institution lower limit of normal as assessed by ECHO or MUGA.
- •3. Major abdominal surgery or peritonitis within six weeks prior to study treatment.
- •4. Unresolved bowel obstruction, sub-occlusive disease or the presence of brain metastases.
- •5. History of allergic reactions to carboplatin, platinum containing compounds or mannitol and/or hypersensitivity to PLD or to any of the excipients.
- •6. Unable to undergo imaging by either CT scan or MRI.
- •7. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications.
- •8. Breast feeding
- •9. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
- •10. Known HIV positive status, active hepatitis B or C status.
- •11. Is taking concurrent (or within 4 week prior to registration) chemotherapy, immunotherapy, radiotherapy, hormone replacement therapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed.
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