NL-OMON50738已完成不适用
A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 Alone and in Combination with Palbociclib in Women with Estrogen Receptor Positive, HER2-Negative Advanced Breast Cancer - G1T48-01 (3652/0007)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
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
- 年龄范围
- 18 至 99（—）
入选标准
- •For a patient to be eligible for participation in this study, all of the
- •following criteria must apply. A full list of inclusion criteria are provided
- •in Section 7.1.1 of the study protocol.
- •Age 18 years or older females (postmenopausal only in Part 1 and any
- •menopausal status in Parts 2 and 3; pre- and peri-menopausal women in Parts 2
- •and 3 must be chemically or surgically postmenopausal)
- •Histological or cytological confirmation of adenocarcinoma of the breast with
- •evidence of metastatic or locally advanced disease, which is not amenable to
- •surgical resection ± radiation therapy with curative intent
- •Documented ER-positive tumor, defined as >= 1% positive stained cells
- •utilizing an assay consistent with local standards. The tumor may be
- •progesterone receptor positive or negative.
- •Documented HER2-negative tumor per 2017 College of American Pathologists
- •(CAP) criteria
- •Not eligible for standard therapy that would confer clinical benefit to the
- •For Parts 1 and 2 of the study, objective evidence of either progression
- •after an AI for metastatic/locally advanced disease OR recurrence while on or
- •within 12 months of the end of adjuvant treatment with an AI
- •For Part 3, patients must meet at least ONE of the following:
- •- Received >= 24 months of endocrine therapy in the adjuvant setting prior to
- •recurrence or progression
- •- Received >= 6 months of endocrine therapy in the advanced/metastatic setting
- •prior to progression
- •Not eligible for standard therapy that would confer clinical benefit to the
- •For Part 1 of the study, evaluable or measurable disease as defined by
- •RECIST, Version 1.1
- •For Parts 2 and 3 of the study, approximately 75% of enrolled patients must
- •have measurable disease as defined by RECIST, Version 1.1
- •Exposure to the following:
- •- Part 1: <= 3 lines of prior cytotoxic chemotherapy
- •- Part 2: <= 1 line of prior cytotoxic chemotherapy
- •- Part 1 and Part 2:
- •o <= 3 prior endocrine therapies in the metastatic setting
- •o Prior CDK4/6 inhibitor therapy and/or everolimus is allowed
- •o <= 1 prior line of endocrine therapy in the metastatic setting
- •o <= 1 prior line of cytotoxic chemotherapy in the metastatic setting
- •o Prior CDK4/6 inhibitor therapy is not allowed
- •o Prior everolimus is allowed
- •Required washout for FES PET (Parts 1 and 2 only), if applicable
- •- >= 5-week interval since the last use of tamoxifen (or other selective
- •estrogen receptor modulators [SERMs]) or fulvestrant (or other SERDs)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy > 12 weeks
- •Adequate bone marrow reserve and organ function as demonstrated by the
- •following laboratory values:
- •- Hemoglobin >= 9 g/dL
- •- Absolute neutrophil count (ANC) >= 1.5 × 109/L
- •- Platelet count >= 100 × 109/L
- •- Estimated glomerular filtration rate >= 50 mL/minute/1.73 m2
- •- Total bilirubin <= 1.5 × ULN
- 另有 1 项未显示
排除标准
- •A patient will not be eligible for participation in this study if any of the
- •following criteria apply. A full list of exclusion criteria are provided in
- •Section 7.1.2 of the study Protocol.
- •Patients with immediately life-threatening or rapidly progressive disease or
- •those who experience rapid visceral recurrence during adjuvant endocrine therapy
- •Known active uncontrolled or symptomatic central nervous system (CNS)
- •metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by
- •clinical symptoms, cerebral edema, and or progressive growth. Patients with a
- •history of CNS metastases or cord compression are eligible if they have been
- •definitively treated (eg, radiotherapy, stereotactic surgery) and clinically
- •stable (including patients with residual CNS symptoms/deficits) off
- •enzyme-inducing anticonvulsants and steroids for at least 28 days prior to the
- •first dose of study drug (patients may continue to receive non-enzyme-inducing
- •anticonvulsants throughout the study if needed)
- •Major surgery, chemotherapy, radiotherapy, or other anticancer therapy within
- •14 days of first dose of study drug
- •Prior hematopoietic stem cell or bone marrow transplantation
- •Blood transfusions or hematopoietic growth factor therapy within 14 days
- •prior to the first dose of study drug
- •Concurrent use of prohibited medications
- •Any unresolved toxicities from prior surgeries or therapies > Grade 1 (Common
- •Terminology Criteria for Adverse Events [CTCAE] Version 5.0) at the time of
- •starting study drug with the exception of alopecia (any grade) and Grade 2
- •peripheral neuropathy
- •Cardiac criteria as outlined in Section 7.1.2 of the study protocol
- •Known clinically significant history of liver disease (excluding metastases
- •to the liver)
- •Unexplained symptomatic endometrial disorders
- •Any evidence of severe or uncontrolled systemic diseases, which in the
- •investigator opinion makes it undesirable for the patient to participate in the
- •study or that would jeopardize compliance with the protocol
- •Known chronic, active infection
- •Refractory nausea and vomiting, chronic gastrointestinal (GI) disease, GI
- •ulcer, GI bleeding, inability to swallow the formulated product, or previous
- •significant bowel resection that would preclude adequate absorption of study
- •History of other malignancies, except for the following: (1) adequately
- •treated basal or squamous cell carcinoma of the skin; (2) curatively treated a)
- •in situ carcinoma of the uterine cervix, b) superficial bladder cancer; or (3)
- •other curatively treated solid tumor with no evidence of disease for >= 3 years
- •For Part 3 of the study, prior CDK4/6 inhibitor therapy, oral SERDs, or
- •selective estrogen receptor covalent antagonists (SERCAs) in any setting
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