CTIS2023-504931-42-00招募中1 期
A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies - MK-1026-003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 502
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 65+（—）
- 性别
- All
入选标准
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to allocation, Part 1 and Part 2 (Cohorts A to C) Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with At least 2 lines of prior therapy (Part 1 only) Part 2 Cohort A: CLL/SLL participants who are relapsed or refractory to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi), and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines Part 2 Cohort B: CLL/SLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment naive Part 2 Cohort C: CLL/SLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy Has active disease for CLL/SLL clearly documented to initiate therapy Has evaluable core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate at Screening (optional for participants enrolling in Part 1), Part 2 (Cohorts D to G) Has a confirmed diagnosis of and response to previous treatment of one of the following: Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D) Participants with pathologically confirmed mantle-cell lymphoma (MCL), documented by either overexpression of cyclin D1 or t(11;14), who are relapsed or are refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort E) Participants with marginal zone lymphoma (MZL) (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort F) Participants with follicular lymphoma (FL) who are relapsed or refractory to chemoimmunotherapy, immunomodulatory agents (i.e. lenalidomide plus rituximab) (Cohort G), Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral computed tomography (CT) scan, Has a lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate (Cohort D) at Screening, Part 2 (Cohort H): confirmed diagnosis of Waldenström’s macroglobulinemia (WM); participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis); immunoglobulin M (IgM) =450 mg/dL; or bone marrow infiltration of 10% Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at Screening or a lymph node biopsy from an archival, Has a life expectancy of at least 3 months, based on the investigator assessment, Has the ability to swallow and retain oral medication, Participants who are Hepatitis B surface antigen (HBsAg)-positive are eligible if they have received Hepatitis B
排除标准
- •Has active HBV/HCV infection (Part 1 and Part 2), Has a history of malignancy =3 years before providing documented informed consent. Participants with basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy are not excluded. Participants with low-risk, early-stage prostate cancer (T1-T2a, Gleason score =6, and prostate-specific antigen <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease (SD) are not excluded, Has active central nervous system (CNS) disease, Has an active infection requiring systemic therapy, Has received prior systemic anti-cancer therapy within 4 weeks prior to allocation, Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention, Has any clinically significant gastrointestinal abnormalities that might alter absorption, History of severe bleeding disorders
研究者
相似试验
进行中（未招募）
1 期
A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid ArthritisEUCTR2020-002673-10-HUEli Lilly and Company80
进行中（未招募）
1 期
A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Investigational Agents in Combination with Etoposide and Cisplatin or Carboplatin for the First Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)Extensive-Stage Small Cell Lung CancerEUCTR2020-005649-17-ATMerck Sharp & Dohme LCC, a subsidiary of Merck & Co., Inc.120
进行中（未招募）
1 期
A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic MalignanciesMedDRA version: 20.0Level: PTClassification code 10003899Term: B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 100000004851MedDRA version: 21.1Level: LLTClassification code 10054693Term: Von Waldenstrom macroglobulinemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-002324-36-CZMerck Sharp & Dohme LLC450
进行中（未招募）
1 期
A Phase 2 Study of belzutifan (MK-6482) Monotherapy in Participants with Advanced Pheochromocytoma/Paraganglioma (PPGL) or Pancreatic Neuroendocrine Tumor (pNET)EUCTR2020-005028-13-SEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.140
进行中（未招募）
不适用
A study to evaluate the effects of palifermin in reducing the difficulty of swallowing in patients receiving chemoradiotehrapy and chemotherapy in lung cancer patientsEUCTR2004-003116-33-DESwedish Orphan Biovitrum (Sobi) AB (publ)100