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临床试验/EUCTR2021-000845-42-HR
EUCTR2021-000845-42-HR进行中（未招募）1 期

Impact of time of alpelisib administration, concomitant fasting and low carbohydrate diet on alpelisib toxicity and efficacy; a pilot randomized controlled phase IIb trial - ITACA

CCGCRO0 个研究点目标入组 60 人开始时间: 2022年5月16日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
60
研究概览入排标准研究者记录与标识符相似试验

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
All

入选标准

  • •1. Patient is an adult male or female (= 18 years of age) with advanced (loco regionally recurrent not amenable to curative therapy or metastatic) hormone receptor-positive, HER2-negative breast cancer
  • •2. Patient has documented evidence of a mutation in the PIK3CA gene as determined in tumor tissue or plasma by a local laboratory.
  • •3. Written informed consent
  • •4. If female, then the patient is postmenopausal. Postmenopausal status is defined either by:
  • •- Prior bilateral oophorectomy
  • •- Age =60
  • •- Age <60 and amenorrhea for =12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and Follicle-stimulating Hormone (FSH) and estradiol in the postmenopausal range per local normal range
  • •5. Patient has evidence of recurrence or progression during or after AI therapy (i.e. letrozole, anastrozole, exemestane) or AI and CDK 4/6i therapy (ribociclib, palbociclib, abemaciclib). AI therapy does not need to be the latest treatment regimen.
  • •Version1 dated 01Mar2021
  • •Confidential
  • •Protocol CBYL719A01T Croatian Cooperative Group for Clinical Research in Oncology
  • •6. Patient has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory.
  • •7. Patient has adequate bone marrow and organ function as defined by the following laboratory values:
  • •1) Absolute neutrophil count = 1.5 × 109/L
  • •2) Platelets = 100 × 109/L
  • •3) Hemoglobin = 9.0 g/dL
  • •4) Potassium, magnesium and calcium (corrected for serum albumin)
  • •within normal limits or = grade 1 according to National Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 if judged clinically not significant by the Treating Physician, or corrected with supplements
  • •5) INR = 1.5
  • •6) Creatinine clearance > 50% LLN
  • •7) In absence of liver metastases, alanine aminotransferase (ALT)
  • •and aspartate aminotransferase (AST) = 2.5 × ULN. If the patient has liver metastases, ALT and AST = 5 × ULN
  • •8) Total serum bilirubin < ULN (or = 1.5 × ULN if liver metastases are present, or total bilirubin = 3.0 × ULN and direct bilirubin in normal range for patients with Gilbert’s syndrome)
  • •9) Fasting plasma glucose (FPG) = 140 mg/dL (7.7 mmol/L)* and glycosylated Hemoglobin (HbA1c) = 6.4% (both criteria have to be met) 10) Fasting Serum Amylase = 2 × ULN
  • •11) Fasting Serum Lipase = ULN
  • •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 60

排除标准

  • •1) Patient has history of hypersensitivity to any drugs or metabolites of PI3K inhibitor or any of the excipients of alpelisib.
  • •2) Patient with established diagnosis of diabetes mellitus type I or uncontrolled type II.
  • •3) Patient has a known history of Steven Johnson’s syndrome or toxic epidermal necrolysis.
  • •4) Patient has a known history of Human Immunodeficiency Virus (HIV) infection.
  • •5) Patient has had surgery within 14 days prior to starting program drug or has not recovered from major adverse reactions.
  • •6) Patient has not recovered to grade 1 or better (except for alopecia) from related adverse reactions of prior antineoplastic therapies.
  • •7) Patient has other prior or concurrent malignancy, with the exception of adequately treated basal or squamous cell skin cancer or other in situ cancer, or any other cancer from which the patient has been disease-free for = 3 years.
  • •8) Patient has central nervous system (CNS) involvement, except for patients fulfilling the following 3 criteria:
  • •- completed prior therapy (including radiation and/or surgery) for CNS metastases = 28 days prior to the start of program treatment and
  • •- CNS tumor is clinically stable at the start of program treatment and
  • •- patient is not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases
  • •9) Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of alpelisib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • •10) Patient who has other concurrent severe and/or uncontrolled medical conditions that would, in the Treating Physician’s judgment, contraindicate administration of alpelisib (e.g. active or uncontrolled severe infection, chronic active hepatitis, immunocompromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =6 months prior to enrolment, serious uncontrolled cardiac arrhythmia, symptomatic pericarditis, etc.).
  • •11) Patient who is concurrently being treated with drugs known to be strong inhibitors or inducers of the isoenzyme CYP3A; switching to different medications prior to start of program treatment is allowed within the last 5 days prior to starting program treatment.
  • •12) Patient is currently receiving or has received systemic corticosteroids = 2 weeks prior to start of program treatment, or who have not fully recovered from adverse reactions of such treatment.
  • •Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
  • •13) Male patient who does not apply highly effective contraception during the treatment with alpelisib and through the duration as defined below after the final dose of alpelisib.
  • •- Sexually active males should use a condom during intercourse while taking drug and for at least 4 weeks after stopping alpelisib and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.

研究者

发起方
CCGCRO

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Impact of time of alpelisib administration,... | 临床试验