Extensive Disease Small Cell Lung Cancer MedDRA version: 16.0 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)
Conditions
Interventions
Product Code: LY2940680
Pharmaceutical Form: Capsule
Current Sponsor code: LY2940680
Other descriptive name: LY2940680
Concentration uni
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1b Determine a safe and tolerable Phase 2 dose of LY2940680 in combination with carboplatin and etoposide followed by LY2940680 in patients with extensive-stage SCLC. Phase 2 Progression-free survival. ; Secondary Objective: Phase 1b • The pharmacokinetic parameters of LY2940680, its active metabolite, LSN3185556, carboplatin, and etoposide • Antitumor activity • Explore the changes induced by LY2940680 in combination with carboplatin and etoposide in biomarkers in skin samples Phase 2 To compare LY2940680 in combination with carboplatin and etoposide followed by LY2940680 with that of carboplatin and etoposide plus placebo followed by placebo with regard to the following: • Overall Survival (OS) • Change in tumor size (CTS) • overall response rate (ORR) and clinical benefit rate • Safety profile of LY2940680 when administered in combination with carboplatin and etoposide • Characterize pharmacokinetics (PK) of LY2940680, its metabolite LSN3185556, carboplatin, and etoposide ; Primary end point(s): Phase 1: Determination of a safe and tolerable Phase 2 dose Phase 2: Progression-free survival ; Timepoint(s) of evaluation of this end point: Phase 1: After all patients have completed at least 1 cycle of study treatment Phase 2: -PFS: Baseline to measured progressive disease or date of death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety and toxicity 2. PK parameters including AUC and Cmax 3. Tumor measurements 4. Overall survival ; Timepoint(s) of evaluation of this end point: 1. Safety: during the entire study drug treatment phase and 30 days after discontinuation 2. PK: before and after dose on days 1,2,3 in cycles 1 and 2 and days 1 and 2 of cycle 7. 3. Tumor measurements: baseline and every 2nd treatment cycle 4. Overall Survival: Baseline until death of any cause | — |
Countries
Belgium, Canada, Korea, Republic of, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed