EUCTR2014-002338-29-GR进行中（未招募）1 期
A PHASE 1B/2 MULTI-CENTER, OPEN LABEL, DOSE- ESCALATION STUDY TO DETERMINE THE MAXIMUM TOLERATED DOSE, SAFETY, AND EFFICACY OF ACY-1215 (RICOLINOSTAT) IN COMBINATION WITH POMALIDOMIDE AND LOW-DOSE DEXAMETHASONE IN PATIENTS WITH RELAPSED-AND-REFRACTORY MULTIPLE MYELOMA
Acetylon Pharmaceuticals, Inc.0 个研究点目标入组 95 人开始时间: 2016年3月4日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
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
- •Patients meeting the following criteria are to be enrolled in the study:
- •1. Must be able to understand and voluntarily sign an ICF.
- •2. Must be = 18 years of age at the time of signing the ICF.
- •3. Must be able to adhere to the study visit schedule and other protocol requirements.
- •4. Must have a documented diagnosis of MM and have relapsed-and-refractory disease. Patients must have received at least 2 lines of prior therapies. Patients must have relapsed after having achieved at least SD for at least one cycle of treatment to at least one prior regimen and then developed PD. Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease).
- •5. Must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen).
- •6. Must not be a candidate for autologous stem cell transplant (ASCT), has declined the option of ASCT, or has relapsed after prior ASCT.
- •7. Must have measurable levels of myeloma paraprotein in serum (= 0.5 g/dL) or urine (= 0.2 g/24 hours). Nonsecretory myeloma and serum free light chain (SFLC)-only myeloma are excluded.
- •8. Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- •9. FCBP must have a negative serum or urine pregnancy test (must be serum for study participants in Canada), as described in Appendix 9.3 for the POMALYST REMS™ program (in the United States [US]) and Appendix 9.4 for the RevAid® program (in Canada). FCBP and males must either commit to continued abstinence from heterosexual intercourse or must abide by birth control requirements as described in Appendix 9.3 for the POMALYST REMS™ program (in US) and Appendix 9.4 for the RevAid® program (in Canada). The European Pomalidomide Pregnancy Prevention Risk Management Plans are described in Appendix 9.5.
- •10. Must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study.
- •11. Must agree not to share study medication with another person.
- •12. Must be able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulated, with an international normalized ratio (INR) of 2 to 3.
- •13. Must be registered into the mandatory POMALYST REMS™ program, and be willing and able to comply with the requirements of the POMALYST REMS™ program (or RevAid® for study participants in Canada).
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Patients meeting any of the following criteria will be excluded from enrollment in the study:
- •1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the ICF, including nonsecretory myeloma or SFLC-only myeloma.
- •2. Any serious concurrent medical conditions, laboratory abnormality, or psychiatric illness that might make the patient non-evaluable, put the patient’s safety at risk, or prevent the patient from following the study requirements.
- •3. Pregnant or lactating females.
- •4. Prior therapy with histone deacetylase (HDAC) inhibitor or pomalidomide.
- •5. Any of the following laboratory abnormalities:
- •ANC < 1,000/µL (hematopoietic growth factors will not be permitted during screening in the Phase 1 or Phase 2 segments of the study or in Cycle 1 of the Phase 1b segment of the study) in either segment of the study.
- •Platelet count < 75,000/µL for patients in whom < 50% of bone marrow nucleated cells are plasma cells, and < 50,000/µL for patients in whom = 50% of bone marrow nucleated cells are plasma cells.
- •Hemoglobin < 8g/dL (< 4.9 mmol/L; prior red blood cell [RBC] transfusion is permitted).
- •Creatinine clearance < 45 mL/min according to Cockcroft-Gault formula. If creatinine clearance calculated from the 24-hour urine sample is = 45 mL/min, patient will qualify for the study.
- •Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST), or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) > 3.0 × ULN.
- •Serum total bilirubin > 2.0 mg/dL
- •6. Prior history of malignancies, other than MM, unless the patient has been free of the disease for = 3 years. Exceptions include the following:
- •Basal or squamous cell carcinoma of the skin
- •Carcinoma in situ of the cervix or breast
- •Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- •7. Corrected QT interval using Fridericia’s formula (QTcF) value > 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at screening; previous history of drug-induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG).
- •8. Positive human immunodeficiency virus (HIV), hepatitis B virus (HBV) and known or suspected active hepatitis C virus (HCV) infection.
- •9. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (such as Steven Johnson Syndrome). Hypersensitivity, such as rash, that can be medically managed is allowable.
- •10. Peripheral neuropathy = Grade 2 despite supportive therapy.
- •11. Radiotherapy or systemic therapy (standard or an investigational or biologic anticancer agent) within 14 days of initiation of study drug treatment.
- •12. Current enrollment in another clinical study involving treatment and/or is receiving an investigational agent for any reason
- •13. Inability or unwillingness to comply with birth control requirements or any of the POMALYST REMS™ or RevAid® (region-specific), per Appendix 9.3 and Appendix 9.4, respectively, or to the European Pomalidomide Pregnancy Prevention Risk Management Plans, per Appendix 9.5.
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