EUCTR2012-003174-83-GB进行中（未招募）1 期
A Phase 1b/2 Double-Blind Randomized Trial of the Hedgehog/SMO Antagonist LY2940680 in Combination with Carboplatin and Etoposide Followed by LY2940680 versus Carboplatin and Etoposide Plus Placebo Followed by Placebo in Patients with Extensive-Stage Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •[1] Histological or cytological diagnosis of SCLC, including malignant pleural effusion that is extensive stage per the International Staging System
- •[2] Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance status schedule (Oken et al. 1982).
- •[3] No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC.
- •[4] Prior radiation therapy allowed to <25% of the bone marrow. Patients who have received prior radiation to the whole pelvis or chest for the treatment of SCLC are not eligible. Prior radiotherapy must be completed at least 2 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- •[5] At least 1 unidimensionally measurable lesion meeting RECIST version 1.1 (Eisenhauer et al. 2009). A measurable lesion is defined as a lesion that can be accurately measured in at least 1 dimension and is =20 mm with conventional techniques or is =10 mm with spiral computed tomography (CT) scan (longest diameter to be recorded). Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements.
- •[6] Adequate organ function including the following:
- •a. Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 x 109/L, platelets =100 x 109/L, and hemoglobin =9 g/dL.
- •b.. Hepatic: bilirubin =1.5 times the upper limit of normal (ULN), alkaline phosphatase (AP), ALT and aspartate transaminase (AST) =3.0 x ULN (AP, AST, and ALT =5 x ULN is acceptable if liver has tumor involvement).
- •c.Renal: calculated creatinine clearance (CrCl) =50 mL/min based on the standard Cockcroft and Gault formula (Cockcroft and Gault 1976).
- •[7] Estimated life expectancy of at least 12 weeks.
- •[8] For women: Must be surgically sterile, post-menopausal, or compliant with at least 2 forms of medically approved contraceptive precautions during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment, and must not be breast-feeding. For men: Must be surgically sterile or compliant with at least 2 forms of medically approved contraceptive precautions during and for 6 months after the treatment period.
- •[9] Patient compliance and geographic proximity that allow adequate follow up.
- •[10] Patient must sign an informed consent document.
- •[11] Are = 18 years of age.
- •[12] Availability of a tumor tissue sample.
- •[13] Are able to swallow capsules.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •[14] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •[15] Have previously participated in a study involving LY2940680.
- •[16] Have previously received treatment with carboplatin or etoposide.
- •[17] Have a mixed histological diagnosis of SCLC and NSCLC.
- •[18] Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol.
- •[19] Have an active infection (=38.5ºC and/or receiving IV antibiotic therapy).
- •[20] Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease as defined by the New York Heart Association Class III or IV.
- •[21] Have had recent (within 30 days of study treatment) or concurrent yellow fever vaccination.
- •[22] Have had a prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of non-metastatic prostate cancer, including biochemical relapse only, will be eligible even if diagnosed less than 5 years previously.
- •[23] Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases requiring concurrent corticosteroid therapy. Treated stable CNS metastases are allowed; the patient must be stable after radiotherapy for =2 weeks and off of corticosteroids for =1 week.
- •[24] Presence of clinically significant (eg, symptomatic) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- •[25] Significant weight loss (that is, =10%) over the 6-week period prior to study entry.
- •[26] Concurrent administration of any other antitumor therapy. An exception will be made for non-metastatic prostate cancer patients continuing androgen blockade therapy only or breast cancer patients continuing adjuvant antiestrogen therapy only (for example, an aromatase inhibitor).
- •[27] Females who are breastfeeding.
- •[28] Have corrected QT interval (QTc) of >470 msec on screening electrocardiogram (ECG).
- •[29] Have received medications that are strong inhibitors of CYP3A4 within 7 days prior to receiving study drug.
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