EUCTR2013-001472-38-SE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/Pegylated Liposomal Doxorubicin Combination Chemotherapy With or Without APR-246 - PiSARRO
适应症
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. Archived sections from the original FFPE sample reviewed by a gynecological pathologist confirming High Grade Serous Ovarian Cancer, High Grade Serous Peritoneal Cancer or Primary Fallopian Tube Cancer, and positive IHC staining for p53 assessed according to defined standard (as detailed in the laboratory manual). Cases that do not show p53 staining will not be included.
- •2. Radiologically-confirmed 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.
- •4. Adequate organ function prior to registration:
- •a) Bone Marrow Reserve:
- •? Absolute neutrophil count (ANC) = 1.5 x109/L,
- •? Platelets = 100 x109/L,
- •? Hemoglobin = 9 g/dL.
- •b) Hepatic:
- •? Total bilirubin level < 1.5 x ULN,
- •? ALT and AST < 2.5 x ULN.
- •? Calculated creatinine clearance > 30mL/min.
- •d) Electrolytes
- •? Potassium within institutional normal ranges.
- •5. Toxicities from previous cancer therapies, excluding alopecia, 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.
- •6. If of childbearing potential, negative pre-treatment serum pregnancy test.
- •7. If of childbearing potential, willing to use an effective form of contraception (see below) during chemotherapy treatment and for at least six months thereafter.
- •Such methods include: (if using hormonal contraception this method must be supplemented with a barrier method, preferably male condom).
- •? combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •o intravaginal
- •o transdermal
- •? progestogen-only hormonal contraception associated with inhibition of ovulation:
- •o injectable
- •o implantable
- •? intrauterine device (IUD)
- •? intrauterine hormone-releasing system ( IUS)
- •? bilateral tubal occlusion
- •? vasectomised partner
- •? true sexual abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.
- •?Male condom with spermicide (female condom and male condom should not be used together)
- •8. ECOG performance status of 0 to 1 (Appendix I).
- •9. = 18 years of age.
- •10. Written informed consent obtained prior to any screening procedures and in accordance with federal, local, and institutional guidelines.
- •11. Patient has exhausted all available treatments, including surgery, and is considered a suitable candidate to receive carboplatin/PLD.
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 200
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:
- •a) Myocardial infarct within six months prior to registration,
- •b) New York Heart Association Class II or worse heart failure (APPENDIX II),
- •c) A history of familial long QT syndrome,
- •d) Clinically significant pericardial disease,
- •e) Electrocardiographic evidence of acute ischemia,
- •f) Symptomatic atrial or ventricular arrhythmias not controlled by medications.
- •g) QTc = 480 msec calculated from a single ECG reading or a mean of 3 ECG readings using
- •Fridericia’s correction (QTcF = QT/RR0.33)
- •h) Bradycardia (<40bpm)
- •i) Left ventricular ejection fraction (LVEF) < the institution lower limit of normal as assessed by
- •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.
- •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
- •10. Patients requiring or undergoing concurrant treatment with live vaccines
- •11. Patients requiring or undergoing concurrant treatment with phenytoin.
- •12. Known HIV positive status, active hepatitis B or C status.
- •13. Is taking any concurrent (or within 4 week prior to registration) anti-cancer therapy, immunotherapy, radiotherapy or any ancillary
- •anticancer therapy; or any 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.
- •14. Patients unable to be regularly followed for any reason (geographic, familiar, social, psychological, housed in an institution e.g., prison
- •because of a court agreement or administrative order). Patients who are dependent on the sponsor/CRO or investigational site as well as on the
- •Investigator.
- •15. Use of concomitant treatment with QT/QTc prolonging drugs.
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