CTRI/2017/09/009687进行中（未招募）2 期
A Phase II, Multicenter, Open-label, Two-cohort, Non-comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After CDK 4/6 Inhibitor Treatment
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
- 2 期
- 状态
- 进行中（未招募）
- 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. patient is male or female 18 years or older and has signed informed consent before any trial related activities and according to local guidelines
- •2. Patient is identified PIK3CA mutant status
- •3. Patient has confirmed HER2-negative advanced breast cancer (aBC)
- •4. Patient is postmenopausal woman defined as either: Prior bilateral oophorectomy; Age more than 60; Age less than 60 and amenorrhea for 12 or more months in the absence of chemotherapy,
- •tamoxifen, toremifen, or ovarian suppression and FSH and estradiol in the postmenopausal range per local normal range.
- •If patient is taking tamoxifen or toremifen and age less than 60, then FSH and plasma
- •estradiol levels should be in post menopausal range per local normal range.
- •5. Patients who received less than 14 days of tamoxifen or a NSAI letrozole or anastrozole with or without goserelin or goserelin less than 28 days for aBC prior to cohort assignment are eligible. Patients who are receiving goserelin for reasons other than for aBC treatment are eligible e.g. endometriosis. Patients who received less than 28 days goserelin for aBC are eligible.
- •6. Patient has histological and/or cytological confirmed ER+ and/or PgR positive aBC
- •7. Patients must be Diagnosed with aBC, with documented evidence of progression on or after CDK 4 6 inhibitor treatment For male patients, prior AI treatment is not required.
- •8. Patients must have either:
- •Measurable disease, i.e at least one measurable lesion as per RECIST v1.1 criteria
- •Tumor lesions previously irradiated or subjected to other locoregional therapy will only
- •be considered measurable if disease progression at the treated site after completion of
- •therapy is clearly documented.
- •If no measurable disease is present, then at least one predominantly lytic bone lesion must
- •be present Patients with no measurable disease and only one predominantly lytic bone
- •lesion that has been previously irradiated are eligible if there is documented evidence of
- •disease progression of the bone lesion after irradiation.
- •9. Patient has adequate bone marrow and coagulation function as shown by the following
- •laboratory values:
- •Absolute Neutrophil Count more than 1.5 x 109 per L
- •Platelets more than 100 x 109 per L For patients with hematologic malignancies involving thebone marrow, platelet count more than 75 x 109 per L may be acceptable
- •Hemoglobin more than 9.0 g per dL
- •INR less than 1.5 INR less than 2.0 will be allowed for those patients treated with vitamin K
- •10. Patient has adequate liver function as shown by:
- •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5
- •ULN or less than 5 if hepatic metastases are present
- •Total serum bilirubin less than upper limit of normal or less than or equal to 1.5 x ULN if liver
- •metastases are present or total bilirubin less than or equal to 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilberts Syndrome, defined as
- •presence of several episodes of unconjugated hyperbilirubinemia with normal CBC
- •results including normal reticulocyte count and peripheral blood smear, normal liver
- •function test results, and absence of other contributing disease processes at the time of
- •11. Patient has adequate rena
排除标准
- •1. patient has received prior treatment with any PI3K inhibitors
- •2. Patients with central nervous system involvement unless they meet ALL of the
- •following criteria:
- •At least 4 weeks from prior therapy completion (including radiation and or surgery) to
- •starting the study treatment
- •Clinically stable CNS tumor at the time of screening untreated or without evidence of
- •progressions for at least 4 weeks after treatment as determined by clinical
- •examination and brain imaging MRI or CT during screening period and stable low dose of steroids for 2 weeks prior to initiating study treatment
- •3. patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
- •4. Patient 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 melanoma skin cancer or curatively resected cervical cancer
- •5. Patient has received radiotherapy less than 4 weeks or limited field radiation for palliation less than 2 weeks prior to enrollment, and who has not recovered to grade 1 or better from related side effects of such therapy
- •6. Patient is currently receiving or has received systemic corticosteroids less than 2 weeks prior to starting treatment with alpelisib, or has not fully recovered from side effects of such
- •7. Patient has bilateral diffuse lymphangitic carcinomatosis
- •8. Patients with a known history of HIV seropositivity. Screening for HIV infection at
- •baseline is not required
- •9. Any severe and or uncontrolled medical conditions that would, in the investigators
- •judgment, contraindicate patient participation in the clinical study e.g chronic active
- •hepatitis, severe hepatic impairment, etc
- •10. Patients being treated with drugs recognized as being strong inhibitors or inducers of the
- •isoenzyme CYP3A Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Ietroconazole,
- •Voriconazole, Ritinavir, Telithromycin within the last 5 days prior to study entry
- •11. Patient has a history of noncompliance to medical regimens
- •12. Patient with severe liver impairment Child Pugh score B C
- •13. Patient has impairment of gastrointestinal function or GI disease that may significantly alter the absorption of the study drugs e.g ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection
- •14. Patient has documented pneumonitis which is active and requiring treatment
- •15. Patient has not recovered from all toxicities related to prior anticancer therapies to NCI
- •CTCAE v4.03 Grade less than 1. Exception to this criterion patients with any grade of alopecia
- •are allowed to enter the study
- •16. Patient has had major surgery within 14 days prior to starting treatment with alpelisib or
- •has not recovered from major side effects
- •17. Patient has any of the following cardiac abnormalities:
- •a. symptomatic congestive heart failure
- •history of documented congestive heart failure New York Heart Association
- •functional classification III IV, documented cardiomyopathy
- •Left Ventricular Ejection Fraction <50% as determined by Multiple Gated
- •acquisition scan or echocardiogram
- •b. myocardial infarction less than 6 months prior to enrolment
- •c. unstable ang
研究者
相似试验
进行中（未招募）
1 期
Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2- negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6 treatment with an aromatase inhibitor (AI) or fulvestrantHormone receptor positive, HER2-negative advanced breast cancerMedDRA version: 19.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864EUCTR2016-004586-67-ESovartis Farmacéutica, S.A.160
进行中（未招募）
1 期
A study to assess the efficacy and safety of bb2121 in people who have Myeloma that is not responsive after treatment or who had Myeloma which has returned after a period of treatment.Relapsed and Refractory Multiple Myeloma and High-Risk Multiple Myeloma Having Progressed Within One Year of Initial TreatmentMedDRA version: 16.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851MedDRA version: 20.0 Level: LLT Classification code 10067095 Term: Multiple myeloma progression System Organ Class: 100000004864EUCTR2018-000264-28-ESCelgene Corporation122
进行中（未招募）
1 期
A study to assess the efficacy and safety of bb2121 in people who have Myeloma that is not responsive after treatment or who had Myeloma which has returned after a period of treatment.EUCTR2018-000264-28-FRCelgene Corporation122
进行中（未招募）
1 期
A study to assess the efficacy and safety of bb2121 in people who have Myeloma that is not responsive after treatment or who had Myeloma which has returned after a period of treatment.Relapsed and refractory multiple myeloma (RRMM), multiple myeloma (MM) with progression within 18 months of initial treatment, or MM with inadequate response post autologous stem cell transplant (ASCT) during initial treatment.MedDRA version: 16.1Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 100000004851MedDRA version: 21.1Level: LLTClassification code 10067095Term: Multiple myeloma progressionSystem Organ Class: 100000004864EUCTR2018-000264-28-DECelgene Corporation181
进行中（未招募）
1 期
A study to evaluate the safety and efficacy of CC-90011 in combination with nivolumab in subjects with advanced cancers.Small cell lung cancer (SCLC) and squamous non-small cell lung cancer (sqNSCLC)MedDRA version: 21.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10025126Term: Lung squamous cell carcinoma stage unspecifiedSystem Organ Class: 100000004864EUCTR2019-004194-95-ITCELGENE CORPORATIO135