NCT01739309已完成2 期
Phase 2 Study of a CDK4/6 Inhibitor for Patients With Relapsed or Refractory Mantle Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieve Disease Control Rate (DCR) Which Includes Complete Response (CR), Complete Response Unconfirmed (CRu), Partial Response (PR) or Stable Disease (SD)
研究概览
简要总结
The purpose of this study is to estimate the disease control rate with abemaciclib for relapsed or refractory mantle cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of relapsed or refractory Mantle Cell Lymphoma (MCL) according to the World Health Organization (WHO) classification that has relapsed after, or been refractory to, available standard treatments. However, participants who are intolerant of, or unable to receive a standard treatment are not required to have MCL that has relapsed after, or been refractory to, that specific standard treatment. Pathology must be reviewed and confirmed at the investigational site where participant is entered prior to enrollment
- •Have disease that is assessable according to the Response Criteria for Non- Hodgkin's Lymphomas
- •Have given written informed consent prior to any study-specific procedures
- •Have adequate organ function including:
- •Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 10^9/Liter (L), platelets ≥75 x 10^9/L, and hemoglobin ≥8 grams per deciliter (g/dL)
- •Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN) and alanine aminotransferase (ALT) ≤3.0 times ULN
- •Renal: Estimated creatinine clearance ≥50 milliliter per minute (ml/min)
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- •Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline) except for residual alopecia
- •Are willing to make themselves available for the duration of the study and to follow study procedures
- •Are amenable to compliance with protocol schedules and testing
- •Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
- •Females with child-bearing potential must have a negative serum pregnancy test within 14 days of the first dose of study drug
- •Have a life expectancy of ≥12 weeks
- •Are able to swallow capsules
排除标准
- •Are currently enrolled in, or discontinued within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively, a clinical trial involving an investigational product or non-approved use of a drug or device other than the study drug used in this study, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, pneumonia, inflammatory bowel disease, history of major surgical resection involving the stomach or small bowel)
- •Have symptomatic metastasis to the central nervous system (CNS). Participants may have CNS metastasis that is radiographically or clinically stable for at least 14 days prior to receiving study drug, regardless of whether they are receiving corticosteroids
- •Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug. In addition, recipients of an allogenic stemcell transplant must have discontinued immunosuppressive therapy at least 14 days before study drug administration with no more than Grade 1 acute graft versus-host disease on Day 1 of Cycle 1
- •Females who are pregnant or lactating
- •Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies). Screening is not required for enrollment
- •Have a baseline electrocardiogram (ECG) with any of the following findings: ventricular tachycardia, ventricular fibrillation, abnormal QTcB (defined as ≥450 milliseconds for males and ≥470 milliseconds for females), or evidence of acute myocardial ischemia
研究组 & 干预措施
Abemaciclib
Experimental
200 milligram (mg) abemaciclib administered orally every 12 hours on days 1 through 28 of a 28-day cycle
干预措施: Abemaciclib (Drug)
结局指标
主要结局
Percentage of Participants Who Achieve Disease Control Rate (DCR) Which Includes Complete Response (CR), Complete Response Unconfirmed (CRu), Partial Response (PR) or Stable Disease (SD)
时间窗: From Date of First Dose until Disease Progression or Death or Start of New Anticancer Therapy (Up to 28 Months)
The DCR was estimated based on the Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). DCR was assessed from date of first dose until disease progression or death or start of new anticancer therapy. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms based on CT scan or bone marrow biopsy; CRu = the CR criteria is met and a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product diameter (SPD). PR is \>= 50% decrease in SPD of the six largest nodal masses/no new sites of disease. Progressive Disease (PD) is defined as an increase by 25% in longest diameter, new lesion or assessable disease progression. SD=small changes not meeting the above criteria; DCR and its exact 95% confidence interval (CI) was estimated for treated participants using the Clopper-Pearson method.
次要结局
- Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) TOI and Subscale Scores(Baseline, Cycle 5 (Up To Day 140))
- PK - Terminal Half Life (T 1/2) of Abemaciclib(Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose)
- Overall Survival (OS)(From Date of First Dose until Death Due to Any Cause (Up to 28 Months))
- Percentage of Participants Who Achieve Best Overall Disease Response (BOR) That Includes CR, CRu or PR(From Date of First Dose until Disease Progression (Up to 28 Months))
- Duration of Objective Response (DOR)(From Date of CR, CRu or PR until Disease Progression or Death Due to Any Cause (Up to 28 Months))
- Progression-Free Survival (PFS)(From Date of First Dose until Disease Progression or Death Due to Any Cause (Up to 28 Months))
- Time to Disease Progression(From Date of First Dose Until Disease Progression (Up to 28 Months))
- PK: Volume of Distribution (Vd) of Abemaciclib(Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose)
- Event-Free Survival(From Date of First Dose until Disease Progression, Discontinuation of Treatment, or Death Due to Any Cause (Up to 28 Months))
- Disease-Free Survival(First Dose Until Date of Disease Progression or Time of Occurrence Disease-Free State or CR to Disease Recurrence or Death (Up to 28 Months))
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib(Predose, 1 hour (hr), 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose)
- PK - Area Under the Concentration-Time Curve From Zero to Last Time Point (AUC[0-tlast]) of Abemaciclib(Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose)
- PK: Clearance (CL) of Abemaciclib(Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose)
研究者
研究点 (1)
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