CTRI/2022/04/042205招募中4 期
A Phase IV, prospective, multicenter, open-label, non- comparative, interventional study to assess the safety of alpelisib plus fulvestrant, in men and post-menopausal women with HR-positive,HER2-negative, advanced or metastatic breast cancer (ABC or MBC) with a PIK3CA mutation, whose disease has progressed on or after endocrine treatment. - ALPINIST
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Written informed consent obtained before any trial related activities and according to local guidelines.
- •2. Participants with confirmed PIK3CA mutant ABC or MBC whose disease has progressed on or after endocrine based treatment
- •3. Postmenopausal females and males more than or equal to 18 years old with confirmed HR positive HER2 negative advanced or metastatic breast cancer.
- •Postmenopausal status is defined either by:
- •i) Prior bilateral oophorectomy
- •ii) Age equal to or more than 60 y
- •iii) Age less than 60 y and amenorrheic for 12 or more 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
- •Note: For women with therapy induced amenorrhea serial measurements of FSH andor estradiol are needed to ensure postmenopausal status. Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist LH-RHa goserelin acetate or leuprolide acetate is not permitted for induction of ovarian suppression in this trial.
- •4. Participant has adequate bone marrow and organ function that is considered appropriate to receive study treatment, as per the Investigator’s clinical judgement.
- •5. Adequate liver function as shown by
- •i) In absence of liver metastases alanine aminotransferase ALT and aspartate aminotransferase AST Less than 3 × ULN.
- •ii) If the Participant has liver metastases ALT and AST less than or equal to 5 × ULN elevated AST or AST values must be stable for 2 weeks without evidence of biliary obstruction by imaging done at Investigator’s discretion.
- •iii) Total bilirubin less than 2 × ULN any elevated bilirubin should be asymptomatic at enrollment except for Participants with Gilbert’s syndrome who may only be included if the total bilirubin is less than or equal to 3.0 × ULN or direct bilirubin less than or equal to 1.5 × ULN
- •6. Adequate renal function as shown by
- •i) Creatinine Clearance more than or equal to 35 mL/min using Cockcroft Gault formula
- •7. Fasting plasma glucose FPG less than or equal to 140 mg/dL 7.7 mmol/L and glycosylated hemoglobin HbA1 less than or equal to 6.4% both criteria have to be met.
- •8. ECOG Eastern Cooperative Oncology Group Performance Status less than 2
- •9. Fasting Serum amylase less than or equal to 2 × ULN and Fasting Serum lipase less than or equal to ULN
- •10. Potassium within normal limits or corrected with supplements
- •11. Calcium corrected for serum albumin and magnesium within normal limits or less than or equal to grade 1 if judged clinically not significant by the investigator.
排除标准
- •1. Known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant
- •2. Participant ineligible for endocrine therapy per the investigators judgment
- •3. Participant has received prior treatment with any PI3K inhibitors and/or mTOR inhibitor
- •4. Participant with type I diabetes or not controlled type II based on FPG and HbA1c see inclusion criterion 7
- •5. Participant has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated basal or squamous cell carcinoma non melanomatous skin cancer or curatively resected cervical cancer
- •6. Participant has not recovered to grade 1 or better from related side effects of prior anticancer therapy with the exception of alopecia
- •7. Participants receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry except in cases outlined below Topical applications inhaled sprays eye drops or local injections are allowed. Participants on stable low dose of corticosteroids for at least two weeks prior to enrollment are allowed
- •8. Bilateral diffuse lymphangitic carcinomatosis
- •9. Participants with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required
- •10. Active, bleeding diathesis, or on oral anti-vitamin K medication.
- •11. Participant has impairment of gastrointestinal GI function or GI disease that may significantly alter the absorption of the study drugs
- •12. Participant has any other concurrent severe and/or uncontrolled medical condition that would in the investigators judgment contraindicate participation in the clinical study.
- •13. Participant has documented pneumonitis/interstitial lung disease which is active and requiring treatment
- •14. Participant has active cardiac disease or a history of cardiac dysfunction
- •15. Participants with unresolved osteonecrosis of the jaw
- •16. Participant has a history of severe cutaneous reactions like Stevens-Johnson-Syndrome SJS Erythema Multiforme EM Toxic Epidermal Necrolysis TEN or Drug Reaction with Eosinophilia and Systemic Symptoms DRESS.
- •17. Participant is a nursing lactating or pregnant woman
- •18. Participant is a woman of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during study treatment and at least for 1 week for alpelisib or 1 year for fulvestrant based on prescribing label after the last dose of each study drug whichever comes later.
- •Highly effective contraception methods include:
- •i) Total abstinence when this is in line with the preferred and usual lifestyle of the Participant. Periodic abstinence e.g calendar ovulation symptothermal postovulation methods and withdrawal are not acceptable methods of contraception
- •ii) Female sterilization have had surgical bilateral oophorectomy with or without hysterectomy total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
- •iii) Male sterilization at least 6 months prior to screening. For female Participants on the study the vasectomized male partner should be the sole partner for that Participant
- •iv) Placement o
研究者
相似试验
进行中（未招募）
1 期
Concentration of ofatumumab in the breast milk of lactating women with relapsing forms of multiple sclerosisCTIS2023-505283-11-00ovartis Pharma AG20
招募中
4 期
A clinical trial to study the effect of Capmatinib in Indian patients with Metastatic NSCLC (MET exon 14 skipping mutation positive)CTRI/2022/05/042549ovartis Healthcare Pvt Ltd
已完成
4 期
A prospective Phase IV study at different centers without any competitor,Single dose clinical study to assess the safety and efficacy of glabellar lines DYSPORT® in adult subjects for treatment of glabellar lines moderate-to-severe the area on frontal bone above the nose and between the eyebrowsCTRI/2018/11/016357Cliniexperts Services Private Limited105
招募中
4 期
A clinical study to assess the long-term immune response after primary vaccination and immune response after re-vaccination with typhoid conjugate vaccineCTRI/2019/07/019996Cadila Healthcare Ltd
尚未招募
4 期
Clinical study of Alogliptin in Patients With Type 2 Diabetes MellitusCTRI/2017/04/008410Takeda Pharmaceuticals India Pvt Ltd300