EUCTR2019-000104-15-ES进行中（未招募）1 期
An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy in patients with advanced haematological malignancies. - Phase I/IIa study to evaluate CCS1477 in haem. malignancies
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •1.Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
- •2.Willing and able to participate in all required evaluations and procedures in this study protocol.
- •3.Men and women =18 years of age.
- •4.Eastern Cooperative Oncology Group (ECOG) performance status of =2.
- •5.Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML). Patients will include but are not limited to the following:
- •B-cell non-Hodgkin lymphoma (including Richter’s Syndrome)
- •T-cell non-Hodgkin lymphoma
- •Multiple myeloma
- •AML/secondary AML (patients with acute promyelocytic leukemia (APL) (FAB subtype M3) will be excluded).
- •High-risk MDS; according to revised International Prognostic Scoring System (IPSS-R).
- •6.Must have received standard therapy (for the majority of therapeutic indications - at least 2 prior lines of therapy) - refer to relevant disease guidelines, such as European Society for Medical Oncology (ESMO), International Myeloma Working Group (IMWG) or National Comprehensive Cancer Network (NCCN) guidelines. In circumstances where there may be no standard of care, or intensive treatment would not be tolerable or is refused, patients may be considered eligible for the study upon consultation and agreement between the medical monitor and the treating Investigator.
- •7.Adequate haematologic function defined as:
- •Absolute neutrophil count (ANC) =1000 cells/mm3 (1.0 x 10^9/L).
- •Platelet count without requiring ongoing blood product support =75,000 cells/mm3 (75 x 10^9/L). Platelet transfusions are not permitted within 3 days of screening.
- •Haemoglobin level =80 g/L.
- •This criterion does not apply to AML/MDS patients. Patients with other malignancies involving bone marrow with parameters below the threshold may be considered eligible following discussion with the medical monitor.
- •For AML, WBC must be <10,000/µl.
- •8.Adequate organ function at screening defined as:
- •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 x upper limit of normal (ULN), or AST/ALT =5 x ULN (with underlying liver involvement following discussion with the medical monitor).
- •Total bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, patients with borderline elevation due to underlying liver involvement may be eligible following discussion with the medical monitor).
- •Serum creatinine <1.5 x ULN, OR creatinine clearance =50 mL/min as measured or calculated by Cockcroft and Gault equation, or =30 mL/min in patients with kidney function affected by the underlying malignancy
- •Serum albumin >2.5 g/dL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •Patients must not enter the study if any of the following exclusion criteria are fulfilled
- •1.Treatment with any of the following:
- •Any investigational agent, chemotherapy, immunotherapy or anticancer agents from a previous clinical study within 14 days or 5 half-lives of first dose of study treatment. Shorter wash-out may be considered for immunotherapies after discussion with medical monitor.
- •Strong inducers of CYP3A4 taken within 4 weeks of the first dose of study treatment or whilst on study treatment.
- •Strong inhibitors of CYP3A4, CYP3A4 substrates with a narrow therapeutic range, CYP2C8 substrates with a narrow therapeutic range or CYP3A4 sensitive substrates taken within 2 weeks of the first dose of study treatment or while on study treatment.
- •Washout periods may be reduced for specific medications (eg. statins) following discussion with the medical monitor.
- •Radiotherapy with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks of the first dose of study treatment; palliative radiotherapy to =30% of the bone marrow within 2 weeks of the first dose of study treatment. A shorter wash-out period may be considered for palliative radiotherapy after discussion with medical monitor.
- •Herbal medications taken within 7 days of the first dose of study treatment (4 weeks for St John’s wort) or while on study treatment.
- •Statins; patients should discontinue statins 5 half-lives prior to starting study treatment.
- •Steroids use >10mg daily prednisolone or equivalent within 2 weeks of the first dose of study treatment.
- •Major surgery within 4 weeks of the first dose of study treatment.
- •2.With the exception of alopecia, and CTCAE Grade 2 neuropathy, any unresolved toxicities from prior therapy > Grade 1 at the time of starting study treatment.
- •3.Presence of, or history of, CNS lymphoma, symptomatic leptomeningeal disease, or spinal cord compression.
- •4.History of prior non-haematologic malignancy except for the following:
- •Adequately treated carcinoma in situ or non-melanomatous skin cancer
- •Malignancy treated with curative intent or in remission for >6 months after the last therapy may be eligible after discussion with medical monitor. Maintenance treatment (eg. hormonal therapy) is allowed.
- •5.Any evidence of severe or uncontrolled systemic disease (e.g. current unstable or uncompensated respiratory or cardiac conditions; history of, or active, bleeding diatheses; uncontrolled active systemic infection, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)*), which in the investigator’s opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol.
- •*Active viral infection is defined as requiring antiviral therapy. Screening for chronic conditions is not required.
- •6.Repeatable QTcF prolongation (>480 msec).
- •7.History of severe allergic or anaphylactic reactions or history of hypersensitivity to active or inactive excipients of CCS1477.
- •8.Female patients who are pregnant or breast-feeding at study entry.
- •9.Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
研究者
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