A Clinical Trial in Patients with Extensive Small Cell Lung Cancer

Phase 1

• Conditions: Extensive Disease Small Cell Lung Cancer; MedDRA 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-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-07
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 131

Inclusion Criteria

-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 had an objective response to prior platinum based therapy or had progression < 90 days after the last dose of platinum
-Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
-Have at least 1 measurable lesion using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
-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 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
-Men must be sterile or agree to use an effective method of birth control during the study and for at least 12 weeks following the last dose of LY2606368
-Women must have a negative serum pregnancy test at screening, have another negative urine pregnancy test within 7 days prior to the first dose of LY2606368, and agree to use a highly effective method of birth control during the study and for 12 weeks following the last dose of LY2606368. Women on study must also not breastfeed.
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 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

Exclusion Criteria

-Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
-Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic patients with treated 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.
-Have a second primary malignancy that may affect the results of the study (investigator and study sponsor discretion)
-Have previously completed or withdrawn from this study or any other study investigating LY2606368 or a CHK 1 Inhibitor
-Have serious pre-existing medical conditions (left to the discretion of the investigator)
-Have a serious cardiac condition
- Have QTc interval of > 470 msec on more than one screening ECG
-Have a family history of long QT-syndrome
-Have 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 the patient may have HIV or hepatitis A, B, or C, appropriate assessment should be conducted to determine whether the patient should be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified