A Phase 2, Exploratory Study of Erlotinib and SNDX-275 in Patients With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 5
- 主要终点
- Disease Control Rate (Complete Response, Partial Response, or Stable Disease for at Least 3 Months
研究概览
简要总结
To evaluate the tumor responses to SNDX-275 (entinostat) in combination with continued erlotinib in participants with non-small Cell Lung Carcinoma (NSCLC) who are progressing on erlotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Cytologically or histologically confirmed NSCLC of stage IIIb (pleural effusion) or IV
- •Disease is progressing (either no response to treatment or subsequent relapse after an objective response) on erlotinib treatment, based on at least 2 scans (the last being within 4 weeks of study enrollment and can serve as the baseline scan for the participant's screening into the study)
- •Recovered from any toxicity associated with the most recent cancer treatment (no greater than grade 1 toxicity on Common Terminology Criteria for Adverse Events scale or to prior baseline condition)
- •At least 1 measurable lesion ≥ 20 millimeters (mm) by conventional computed tomography (CT) scan or ≥ 10 mm by spiral CT scan
- •Eastern Cooperative Oncology Group performance score of 0, 1, or 2 and life expectancy of at least 3 months
- •Paraffin-embedded tumor specimen available for correlative studies
- •Male or female over 18 years of age
- •Hemoglobin ≥ 9.0 grams/deciliter; platelets ≥ 75 x 10^9/liter (L); absolute neutrophil count ≥ 1.0 x 10^9/L without the use of hematopoietic growth factors
- •Coagulation tests within the normal range
- •Bilirubin and creatinine less than 2 times the upper limit of normal for the institution
- •Aspartate aminotransferase and alanine aminotransferase less than 3 times the upper limit of normal for the institution
- •Potassium, magnesium and phosphorus within the normal range for the institution (supplementation is permissible)
- •Willing to use accepted and effective methods of contraception during the study (both men and women as appropriate) and for 3 months after the last dose of entinostat
- •Participant or legally acceptable representative has granted written informed consent before any study-specific procedure (including special screening tests) is performed
排除标准
- •Prior stem cell transplant
- •Symptomatic central nervous system involvement
- •Prior treatment with an histone deacetylase inhibitor
- •Concurrent anticancer therapy, with the exception of radiotherapy for a non-target study lesion
- •Currently taking medication(s) on the prohibited medication list
- •Systemic chemotherapy or treatment with an investigational agent within 28 days before enrollment
- •Current use of valproic acid
- •Untreated or unstable brain metastases, or taken steroids for this condition within 4 weeks of study drug administration
- •Currently active second malignancy, or any malignancy within the last 5 years other than cured basal or squamous cell skin carcinoma, cervical carcinoma in situ, or superficial bladder cancer
- •Inability to swallow oral medications or a gastrointestinal malabsorption condition
- •Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection
- •Abnormal cardiac function as defined as clinically significant findings on electrocardiogram (multifocal premature ventricular complexes, ST-T wave changes consistent with myocardial infarction or acute ischemia, QTc greater than 500 milliseconds), tachycardia, or left ventricular ejection fraction less than 40% on multigated acquisition scan
- •Another serious or uncontrolled medical condition within 3 months of enrollment such as hypertension, diabetes mellitus, or suppressed immune system
- •Known hypersensitivity to benzamides
- •Morbid obesity
- •Women who are currently pregnant or breast-feeding
- •Participant is currently enrolled in (or completed within 28 days) another investigational drug study
- •Participant unavailable for on-study or follow-up assessments
- •Participant has any kind of medical, psychiatric, or behavioral disorder that places the participant at increased risk for study participation or compromises the ability of the participant to give written informed consent and/or to comply with study procedures and requirements
研究组 & 干预措施
Erlotinib-responsive
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months.
干预措施: Entinostat (Drug)
Erlotinib-responsive
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months.
干预措施: Erlotinib (Drug)
Erlotinib-nonresponsive
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.
干预措施: Entinostat (Drug)
Erlotinib-nonresponsive
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Disease Control Rate (Complete Response, Partial Response, or Stable Disease for at Least 3 Months
时间窗: At least 3 months
次要结局
- Progression-free Survival Rate(Up to 4 months)