CTIS2023-507274-40-00进行中（未招募）1 期
A Phase 1 Open-Label Study Evaluating the Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination with Ruxolitinib in Myeloproliferative Neoplasm Subjects - M19-753
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 85
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
- •Part 1 and Part 2 of the study are not being conducted within the EEA., Part 4: Subject must have an ECOG performance status = 2., Part 4: Subject must meet laboratory parameters for bone marrow reserves, platelet count, neutrophil count, renal function, hepatic function and enzymes, AST and ALT, Billirubin, coagulation and serum potassium., Part 5: Subjects with a documented diagnosis of primary MF as defined by the WHO classification, post-PV MF, or post-ET MF., Part 5: Subject must be requiring treatment for MF and must either have no prior treatment with a JAK2 inhibitor or have received treatment with ruxolitinib meeting at least one of the following criteria listed in protocol eligibility criteria, Part 5: Subject must have an ECOG performance status = 2., Subjects = 18 years old, Part 3: At screening or baseline (pre-dose on Day 1), subject has QTc interval by Fridericia's correction (QTcF) = 450 msec., Part 3: Subjects with a documented diagnosis of primary or secondary MF, ET, PV or chronic myelomonocytic leukemia (CMML) as defined by the WHO classification., Part 3: Subject must be requiring treatment and have failed or are intolerant to at least one prior therapy and be ineligible for allogeneic stem cell transplantation. Subjects who refuse standard therapy may only be enrolled in regions where permitted by local regulations, Part 3: Subject must have an ECOG performance status = 2., Part 3: Subject must meet laboratory parameters for bone marrow reserves, platelet count, neutrophil count, renal function, hepatic function and enzymes, AST and ALT, Billirubin, coagulation, serum potassium and hypocalcemia., Part 4: Subjects with a documented diagnosis of primary or secondary MF, ET, PV or chronic myelomonocytic leukemia (CMML) as defined by the WHO classification., Part 4: Subject must be requiring treatment and have failed or are intolerant to at least one prior therapy and be ineligible for allogeneic stem cell transplantation. Subjects who refuse standard therapy may only be enrolled in regions where permitted by local regulations.
排除标准
- •Part 1 and Part 2 of the study are not being conducted within the EEA., Part 5: Subject must not have received CYP2C9 inducers within 10 days prior to the first dose of study drugs., Part 3: Subject must not show leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy)., Part 3: Subject must not be currently on medications that interfere with coagulation (including warfarin) or platelet function except for low-dose aspirin (up to 100 mg) and LMWH., Part 3: Subject must not have had prior therapy with a BH3 mimetic compound., Part 3: Subject must not have received strong or moderate CYP3A inhibitors within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of navitoclax., Part 3: Subject must not have received strong CYP3A inducers within 10 days prior to the first dose of navitoclax., Part 4: Subject must not show leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy)., Part 4: Subject must not be currently on medications that interfere with coagulation (including warfarin) or platelet function except for low-dose aspirin (up to 100 mg) and LMWH., Part 4: Subject must not have had prior therapy with a BH3 mimetic compound., Part 4:Subject must not have received strong or moderate CYP3A inhibitors or CYP2C9 within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study drugs., Part 4: Subject must not have received strong or moderate CYP2C9 inhibitors within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study drugs., Part 4: Subject must not have received strong CYP3A or CYP2C9 inducers within 10 days prior to the first dose of study drugs., Part 5: Subject must not have a history of an active malignancy other than MF within the past 2 years prior to study entry, except for: - Adequately treated in situ carcinoma of the cervix uteri - Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin - Asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy., Part 5: Subject must not be currently on medications that interfere with coagulation (including warfarin) or platelet function except for low-dose aspirin (up to 100 mg) and LMWH., Part 5: Subject must not have received strong CYP3A inhibitors within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study drugs., Part 5: Subject must not have received CYP2C9 inhibitors within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study drugs., Part 5: Subject must not have received strong CYP3A inducers within 10 days prior to the first dose of study drugs.
研究者
相似试验
已完成
1 期
avitoclax Monotherapy and in Combination with Ruxolitinib in Myeloproliferative Neoplasm SubjectsMyeloproliferative NeoplasmJPRN-jRCT2080224824AbbVie GK9
进行中（未招募）
1 期
A clinical study evaluating the safety of fat-tissue-derived stem cells from healthy donors as a treatment for dry mouth syndrome after radiotherapy of cancer in the tonsils or base of the tongue.The trial will include participants with Xerostomia ( International Classification of Diseases-10: DQ 838A)MedDRA version: 20.0Level: LLTClassification code 10048223Term: XerostomiaSystem Organ Class: 100000004856EUCTR2018-003856-19-DKDepartment of Otorhinolaryngology, Head and Neck Surgery and Audiology. Rigshospitalet, University Hospital of Cph, DK10
已完成
不适用
A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative ColitisNL-OMON40329Janssen Biologics B.V.4
进行中（未招募）
不适用
A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative ColitisEUCTR2012-004366-18-BEJanssen Biologics B.V.30
进行中（未招募）
1 期
A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitislcerative Colitis in pediatric subjectsMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2012-004366-18-ATJanssen Biologics B.V.30