A Phase 2 Study of Enzastaurin in Participants With Follicular Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
研究概览
简要总结
To evaluate the antitumor activity, as measured by tumor response rate, of enzastaurin in participants with Follicular Lymphoma (FL).
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
- •All participants must:
- •Have had a histologically confirmed diagnosis of Grade 1 or 2 FL, according to World Health Organization classification (Harris et al. 1999), at the original time of diagnosis. Pathology must be confirmed locally prior to enrollment at the investigational site.
- •Have Ann Arbor Stage III or IV disease.
- •Must be chemo-naive OR have relapsed disease after receiving only one prior chemotherapy regimen. The chemotherapy must have been completed at least 6 months prior to first dose of study treatment. Relapse after one prior course of single-agent rituximab treatment (in the chemo-naive setting) is also allowed if completed at least 6 months prior to first dose of study treatment.
- •Participants must not require cytoreductive therapy for at least 3 months from first dose of study treatment, in the opinion of the investigator.
- •Previous radiation therapy is allowed, but should have been limited and must not have included whole pelvis radiation. Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been irradiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria:
- •Are unable to swallow tablets.
- •Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
- •Are receiving concurrent administration of any other antitumor therapy.
- •Are pregnant or breastfeeding.
- •Have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.
研究组 & 干预措施
Enzastaurin
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, oral daily, up to 3 years
干预措施: Enzastaurin (Drug)
结局指标
主要结局
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
时间窗: Baseline to Measured Progressive Disease (up to 1559 Days)
Tumor response rate is defined as the number of responders divided by the number of treated patients. A responder is a patient who exhibits a complete response (CR), complete response unconfirmed (CRu), or partial response (PR) as defined by Cheson et al. CR, the disappearance of target lesions and any pathological lymph nodes \[target or non-target\] taking as reference the baseline sum of diameters in response to treatment; CRu, complete disappearance of all detectable clinical and radiographic evidence of disease, return of spleen to non-palpable if involved, residual lymph node mass greater than 1.5 centimeters (cm) has regressed by more than 75%; PR, 50% decrease in the sum of the products of the greatest diameter (SPD) of the 6 largest dominant masses, no increase of other nodes, liver or spleen and no new sites of disease.
次要结局
- Progression-Free Survival (PFS)(Baseline to Measured Progressive Disease or Death from Any Cause (Up to 1559 Days))
- Time to Response (TtR)(Baseline to Date of Confirmed Response (Up to 890 Days))
- Duration of Response (DoR)(Time of Response to Measured Progressive Disease (Up to 1415 Days))
- Number of Participants With Response With Expression of Protein Biomarkers(Baseline)