A Clinical Trial in Patients with Extensive Small Cell Lung Cancer
- Conditions
- Extensive Disease Small Cell Lung CancerMedDRA version: 20.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-005069-21-GR
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 116
1) Have histological or cytological diagnosis of ED-SCLC and received a prior platinum-based regimen. Cohort 1 must have had an objective response to prior platinum-based therapy with subsequent progression >= 90 days after the last dose of platinum. Cohort 2 must either have not had an objective response to prior platinum based therapy or had progression < 90 days after the last dose of platinum
2) Have a performance status of 0 to 1 on the ECOG scale
3) Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy
4) Have at least 1 measurable lesion using standard techniques by RECIST 1.1
5) have given written informed consent/assent prior to any study-specific procedures
6) are of an acceptable age to provide informed consent according to the local regulations and are at least 18 years of age
7) Have adequate organ function, including:
Hematologic: Absolute Neutrophil Count (ANC) >= 1.5x 10^9/L, platelets >= 100 x 10^9/L, Hemoglobin >= 8 g/dL or >=5 mmol
Hepatic: direct bilirubin <= 1.5 x ULN, ALT and AST <= 2.5 x ULN or <= 5 x ULN (if the liver has tumor involvement)
Renal: Serum creatinine, or measured creatinine clearance, or calculated creatine clearance (using the Chronic Kidney Disease Epidemiology Collaboration (CKP-EPI) equation) < 1.5 x ULN or >= 50 mL/min/1.73 m^2
8) Men must be sterile or agree to use an effective method of contraception or a highly effective method of contraception during the study and for at least 12 weeks following the last dose of LY2606368
9) Women of childbearing potential must have a negative serum pregnancy test at the baseline visit, have another negative urine pregnancy test within 7 days prior to the first dose of LY2606368, agree to use a highly effective method of contraception during the study and for 12 weeks following the last dose of LY2606368 and not be breast-feeding.
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36
1) Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
Each line of therapy is preceded by disease progression. Discontinuation of a regimen without progression (for example, due to toxicity) or a switch of an agent within the same drug class (for example, cisplatin to carboplatin) within a regimen to manage toxicity does not define the start of a new line of therapy. Similarly, maintenance therapy (continuation maintenance or switch maintenance) will not be considered a new line of treatment.
2) Have symptomatic central nervous system (CNS) malignancy or metastasis. Asympomatic patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids to treat CNS metastases. CNS metastases should be stable for at least 14 days by clinical assessment, and patients should not have received corticosteroids to treat CNS metastases within 14 days of the first dose of study drug
3) Have a second primary malignancy that in the judgment of the investigator and Lilly may affect the interpretation of results
4) Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
5) Have previously completed or withdrawn from this study or any other study investigating LY2606368 or a CHK1 inhibitor or have shown hypersensitivity to any of the components of the LY2606368 formulation
6) Have a known serious concomitant systemic disorder (for example, active infection or cardiac disease) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol
7) Have a symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required). If the medical history, symptoms, and/or laboratory values suggest that the patient may have HIV or hepatitis A,B, or C, appropriate assessment should be conducted to determine whether the patient should be excluded
8) Have a serious cardiac condition, such as:
• symptomatic congestive heart failure
• New York Heart Association Class III/IV heart disease
• unstable angina pectoris
• symptomatic or poorly controlled cardiac arrhythmia
• myocardial infarction within the last 3 months
• have a QT interval using Frederica’s correction (QTcF) of >470 msec on more than one screening electrocardiogram (ECG)
• a family history of long-QT syndrome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method