EUCTR2017-000861-58-IT进行中（未招募）1 期
A PHASE II, SINGLE-ARM,OPEN-LABEL STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF IDASANUTLINMONOTHERAPY IN PARTICIPANTS WITH HYDROXYUREA-RESISTANT/INTOLERANT POLYCYTHEMIA VERA. - Evaluate the Eff., Saf., PharmPK, Pharmacodyn of Idasanutlin monotherapy in pts with PV
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adults > 18 years of age.
- •- There must be documentation that the patient has met the revised 2016 WHO criteria for the diagnosis of polycythemia vera.
- •- Hematocrit at the screening and initiation of idasanutlin > 40%.
- •- Phlebotomy-dependent patients with splenomegaly by magnetic
- •resonance imaging (MRI) or computerized tomography (CT) imaging (=
- •450 cm3) or without splenomegaly (< 450 cm3, unpalpable, or prior
- •splenectomy).
- •- Resistance to/intolerance to hydroxyurea according to modified ELN
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0
- •- Patients must be willing to submit the blood sampling and bone
- •marrow sampling for the PK and pharmacodynamic analyses and
- •exploratory biomarkers.
- •- Adequate hepatic and renal function.
- •- For women of childbearing potential: agreement to use non-hormonal contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 weeks after the last dose
- •of idasanutlin.
- •- For men: Agreement to use contraceptive measures, and agreement to refrain
- •from donating sperm during the treatment period and for at least 90 days after the last dose of idasanutlin.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Meets the criteria for post PV MF as defined by the International
- •Working Group-Myeloproliferative Neoplasms Research and Treatment
- •(IWG-MRT).
- •- Blast phase disease (>20% blasts in the marrow or peripheral blood).
- •- Clinically-significant thrombosis within 3 months of screening.
- •- Patients who must receive CYP2C8 inhibitors, substrates and inducers,
- •strong CYP3A4 inducers, or OATP1B1/3 substrates while on study. These
- •must be discontinued 7 days (inhibitors and substrates) or 14 days
- •(inducers) prior to start of study medication.
- •- Patients previously treated with MDM2 antagonist therapies or
- •patients receiving interferon-alpha, anagrelide, or ruxolitinib within 28
- •days or 5 half-lives, or HU within 1 day, or patients receiving any other
- •cytoreductive or investigational agents within 28 days or 5 half-lives of
- •initial dose. Aspirin is permitted per treatment guidelines for PV unless
- •medically contraindicated.
- •- Patients with evidence of electrolyte imbalance such as hypokalemia,
- •hyperkalemia, hypocalcemia, hypercalcemia, hypomagnesemia, and
- •hypermagnesemia of Grade > 1 intensity, as per NCI CTCAE, version 4.0
- •prior to dosing on Cycle 1 Day 1. Treatment for correction of electrolyte
- •imbalances is permitted to meet eligibility.
- •- Neutrophil count < 1.5 × 10^9/L prior to dosing on Cycle 1 Day 1.
- •- Platelet count = 150 × 10^9/L prior to dosing on Cycle 1 Day 1.
- •- Women who are pregnant or breastfeeding.
- •- Ongoing serious non-healing wound, ulcer, or bone fracture.
- •- History of major organ transplant.
- •- Uncontrolled intercurrent illness including, but not limited to hepatitis, concurrent malignancy that could affect compliance with the protocol or interpretation of results, hepatitis A, B, and C, human immunodeficiency
- •virus (HIV)-positive, ongoing or active infection, clinically significant
- •cardiac disease (New York Heart Association Class III or IV),
- •symptomatic congestive heart failure, unstable angina pectoris,
- •ventricular arrhythmia, or psychiatric illness/social situations that would
- •limit compliance with study requirements.
- •- Patients with active GI conditions (Crohn's disease, ulcerative colitis, diverticulosis associated colitis, and Behçet's disease).
- •- Clinically significant toxicity (other than alopecia) from prior therapy that has not resolved to Grade <= 1 (according to the NCI CTCAE, v4.0) prior to Day 1 Cycle 1.
研究者
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