JPRN-jRCT2031230121暂停1 期
A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS - CDK4
Kawai Norisuke0 个研究点目标入组 337 人开始时间: 2023年6月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 337
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •* Part 1A/1D/1E: HR+HER2-BC, HR+HER2+BC, NSCLC, prostate cancer, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests
- •* Part 1B/1C: HR+HER2-BC
- •* Part 1F: Prostate cancer
- •* Part 2A/2B/2C: HR+HER2-BC
- •* Part 2D: CRPC
- •* Part 1: evaluable lesion (including skin or bone lesion only)
- •* Part 2A/2B/2C: measurable lesion per RECIST v1.1
- •* Part 2D: evaluable disease as per PCWG3; participants with bone metastases only are allowed. Participants with biochemical recurrence only are excluded
- •Prior systemic treatment
- •* Part 1: Refractory to or intolerant of existing standard therapies including CDK4/6i, HER2 targeting therapy or approved systemic therapy, or no standard therapy is available
- •* Part 2A: Must have at least 1 line of SOC, including prior CDK4/6i, for advanced/metastatic BC (Prior chemotherapies for advanced disease setting are allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed)
- •* Part 2B: No prior systemic anti-cancer therapies for advanced/metastatic BC
- •* Part 2C: Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal or tamoxifen if pre or perimenopausal; or Progressed while on or within 1 month after the end of the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or endocrine treatment for advanced/metastatic BC if pre or perimenopausal (one previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy)
- •Part 2D: Received prior treatment with abiraterone in any setting; No prior enzalutamide and CDK4/6i (up to 1 prior line of chemotherapy in any setting is allowed)
- •General inclusion criteria
- •* ECOG PS 0 or 1
- •* Adequate renal, liver, and bone marrow function
排除标准
- •* Part 1D: participants who have had a gastrectomy or have dietary or other restrictions that preclude a 10 hour overnight fast or consumption of the high fat, high calorie meal
- •* Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor
- •* Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway
- •* Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
- •* Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- •* Major surgery or radiation within 4 weeks prior to study intervention
- •* Last anti-cancer treatment within 2 weeks prior to study intervention
- •* Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- •* Pregnant or breastfeeding female participant
- •* Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
研究者
相似试验
进行中（未招募）
不适用
A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF IDES IN CHRONIC KIDNEY DISEASE PATIENTSEUCTR2013-005417-13-SEHansa Medical AB
进行中（未招募）
1 期
A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF IDES IN KIDNEY TRANSPLANTATIORemoval of anti-HLA antibodies in patients planned to undergo kidney transplantationEUCTR2014-000712-34-SEHansa Medical AB
已完成
1 期
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects and Exploratory Efficacy of FPP003 Vaccine in Subjects with Psoriasis.PsoriasisSkin - Dermatological conditionsACTRN12619000599178FunPep Co. Ltd.36
进行中（未招募）
1 期
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe HypoglycemiaType 1 Diabetes Mellitus with Impaired Hypoglycemic Awareness and Severe HypoglycemiaMedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 21.1Level: LLTClassification code 10081605Term: Severe hypoglycemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2022-002292-11-DEVertex Pharmaceuticals Incorporated37
进行中（未招募）
不适用
A Phase 1/2 of Peptide Vaccine S-488210 in Patients with Head and Neck Squamous Cell CarcinomaEUCTR2011-005014-12-DEShionogi & Co., Ltd.92