CTRI/2023/08/056738招募中3 期
A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib & Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy - VIKTORIA-1
PSI CRO Pharma India 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
- 3 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
- •Subjects must meet the following inclusion criteria:
- •1.Adults =18 years of age and meet one of the following criteria:
- •a.Women who are postmenopausal, defined as one of the following: i.Women 18–59 years of age (at the time of consent) with cessation of regular menses for =12 consecutive months with no alternative pathological or physiological cause, and serum estradiol and FSH level within the range for postmenopausal females. ii.Women =60 years of age with cessation of menses for =12 consecutive months. iii.Bilateral oophorectomy. iv.Ovarian failure. b.Pre/perimenopausal women with medically-induced menopause
- •c.Male subjects must use a contraceptive method from screening until 1 year after the last dose of study treatment. 2.Negative pregnancy test for women who are not surgically sterile. Contraceptive use from screening until 1 year after the last dose of study treatment.
- •3.Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer
- •4.Confirmed diagnosis of ER and/or PR positive, as per ASCO CAP guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standards
- •5.Documented HER2 IHC negative as per ASCO-CAP 2018 guidance
- •6.Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status by Therascreen®PIK3CA RGQ PCR test and identified PIK3CA status (mutant or non-mutant).
- •7.Subject has radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment
- •8.ECOG performance status of 0–1
- •9.Life expectancy of at least 3 months
- •10.Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal AI
- •11.Resolution of all toxicities related to prior therapies or surgical procedures to NCI CTCAE v.5.0 Grade =1 (except alopecia)
- •12.Left ventricular ejection fraction =50% at baseline
- •13.=2 weeks beyond treatment with a targeted therapy or major surgery and =3 weeks beyond chemotherapy, immunotherapy, and/or radiation therapy and recovered from all acute toxicities prior to randomization (AEs from prior anticancer agents recovered to Grade =1 or lower; except alopecia)
- •14.Adequate bone marrow, hepatic, renal and coagulation function as described in the study protocol
- •15.Must be willing and able to comply with protocol
- •16.Ability to understand the investigational nature of the study and sign the informed consent
排除标准
- •Subjects must NOT meet any of the following exclusion criteria:
- •1.History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for =3 years
- •2.Prior treatment with a PI3K, Akt, or mTOR inhibitor
- •3. > one prior treatment with chemotherapy for advanced disease (prior adjuvant or neoadjuvant chemotherapy is permitted)
- •4. > 2 lines of prior endocrine therapy treatment
- •5.Bone only disease that is only blastic with no soft tissue component
- •6.Subjects with type 1 diabetes or uncontrolled type 2 diabetes
- •7.Active HIV infection (testing not mandatory; refer to protocol).
- •8.Known seropositive for or active viral infection with hepatitis B virus (refer to protocol)
- •9.Known seropositive for, or active infection with hepatitis C virus (refer to protocol)
- •10.Known and untreated, or active, brain or leptomeningeal metastases
- •a.Subjects with previously treated CNS metastases must meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment =4 weeks prior to enrollment
- •11.Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term
- •12.History of clinically significant cardiovascular abnormalities as described in the study protocol
- •13.Gastrointestinal tract disease resulting in an inability to absorb oral medication
- •14.History of acute pancreatitis within 12 months of screening or past medical history of chronic pancreatitis
- •15.Unable to swallow oral medication tablets/capsules
- •16.Known hypersensitivity to the study drugs or their components
- •17.History of pulmonary embolus or deep vein thrombosis diagnosed and/or treated within the previous 6 months
- •18.History of drug induced pneumonitis or interstitial lung disease
- •19.Current uncontrolled medical conditions that, in the opinion of the Investigator, could limit a subject’s ability to undertake study therapy or comply with study requirements
- •20.Pregnant or breast-feeding women
- •21.Concurrent participation in another clinical trial
研究者
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