A Phase II Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Carcinoma
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
- Progression-free Survival for at Least 6 Months (PFS-6)
研究概览
简要总结
The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma.
- •All participants must have measurable disease.
- •Participants must have at least one "target lesion" to be used to assess response on this protocol.
- •Participants must not be eligible for a higher priority GOG protocol, if one exists.
- •Participants who have received one prior regimen must have a GOG Performance Status of 0, 1, or
- •Participants who have received two prior regimens must have a GOG Performance Status of 0 or
- •Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
- •Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to registration.
- •Participants must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
- •Participants must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease.
- •Participants of child-bearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment.
排除标准
- •Participants with previous enzastaurin treatment.
- •Participants who have received radiation to more than 25% of marrow-bearing areas
- •Participants with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
- •Participants who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Participants who are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Concomitant Medications for a discussion of enzyme inducing anti-epileptic drugs [EIAEDs]).
- •Participants who are receiving concurrent administration of any other systemic anticancer therapy except for a biphosphonate if patient has bony metastases.
- •Participants who have received prior therapy with non-cytotoxic agents (i.e. bevacizumab).
- •Participants with serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.
研究组 & 干预措施
A
干预措施: enzastaurin (Drug)
结局指标
主要结局
Progression-free Survival for at Least 6 Months (PFS-6)
时间窗: Baseline through 6 months
Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Number of Participants With Adverse Events and Severe Adverse Events
时间窗: Baseline through end of study (Up to 45 months)
Data presented are the number of participants who experienced 1 or more adverse events (AEs) (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
次要结局
- Overall Survival(Baseline through end of study (Up to 45 months))
- Duration of Progression-Free Survival(Baseline to disease progression (Up to 38 months))
- Prognostic Factors: Platinum Sensitivity(Baseline)
- Prognostic Factors: Performance Status(Baseline)