A Clinical Study in Patients with Small Cell Lung Cancer

• Conditions: Extensive Disease Small Cell Lung Cancer; MedDRA version: 16.0Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003174-83-BE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-27
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

[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

Exclusion Criteria

[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.

Study & Design

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