A Phase 2, Open-Label, Multicenter Study of Single-Agent Enzastaurin in Patients With Relapsed Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate)
研究概览
简要总结
The purpose of the study is to determine the efficacy and safety of enzastaurin in participants with Cutaneous T-Cell Lymphoma (CTCL) who failed prior therapies.
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
- •Histologically confirmed mycosis fungoides or Sezary Syndrome.
- •Stage IB to IVB disease at screening.
- •Recurrent or refractory disease after at least 1 prior systemic therapy.
- •Have adequate organ function defined as:
- •Hepatic: total bilirubin ≤1.5 times the upper limit of normal (ULN); alanine transaminase/aspartate transaminase (ALT/AST) ≤2.5 times the ULN.
- •Renal: serum creatinine ≤1.5 times the ULN.
- •Adequate bone marrow reserve: platelets ≥75 * 10^9/Liters (L); absolute neutrophil count (ANC) ≥1.0 * 10^9/L.
- •At least 30 days must have passed since other treatment for CTCL.
排除标准
- •Receiving concurrent treatment for CTCL.
- •Unable to swallow tablets.
- •Receiving high potency oral or topical steroids. Low potency oral steroid may be permitted in participants who have been on a stable dose for at least 4 weeks prior to screening. Oral or topical antihistamine is allowed.
- •Unable to discontinue use of carbamazepine, phenobarbital, or phenytoin.
- •Have a serious concomitant systemic disorder or Human Immunodeficiency Virus (HIV).
- •Have a serious cardiac condition such as myocardial infarction within past 6 months, angina, or heart disease as defined by the New York Heart Association (NYHA) Class III or IV.
- •Have electrocardiogram (ECG) abnormalities.
- •Are pregnant or breastfeeding.
研究组 & 干预措施
Enzastaurin
Open Label
干预措施: Enzastaurin (Drug)
结局指标
主要结局
Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate)
时间窗: Baseline to measured Progressive Disease (PD) [up to 9 cycles (28-day cycles)]
Response rate is percentage of participants with confirmed CR or PR as per modified Severity-Weighted Assessment Tool (mSWAT) for MF group; mSWAT and Sezary count for SS group. mSWAT is a weighted sum of percent (%) of total body surface area attributed to skin lesions which yield a mSWAT score \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks; PR: ≥50% mSWAT score reduction from baseline). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline). Response rate is calculated as total number of participants with CR or PR from the start of study treatment until PD or recurrence divided by the number of participants treated, then multiplied by 100.
次要结局
- Duration of Response for Responding Participants(Time of response to PD [up to 9 cycles (28-day cycles)])
- Time to Progression(Baseline to measured PD [up to 9 cycles (28-day cycles)])
- Time to Objective Response for Responding Participants(Baseline to confirmed response [up to 9 cycles (28-day cycles)])
- European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Utility Score United States (US) Index (Participant-Reported Measure of Health-State Utility)(Baseline to study completion [up to 9 cycles (28-day cycles)], end of treatment reported)
- Pruritus 5-Item Severity Assessment Questionnaire (Participant-Reported Experiences With Pruritus)(Baseline to study completion [up to 9 cycles (28-day cycles)], end of treatment reported)
- Change From Baseline in Itchy Quality of Life (QoL) Domain and Total Scores (Participant-Reported Experiences With Pruritus)(Baseline, up to study completion [up to 9 cycles (28-day cycles)], end of treatment reported)
- Number of Participants With Adverse Events (AEs) or Deaths (Safety and Tolerability of Enzastaurin)(Baseline to study completion [up to 9 cycles (28-day cycles)] plus 30-day safety follow-up)