Subjects with histologically or cytologically confirmed, extensive disease SCLC without prior systemic antitumor therapy are eligible. Subjects should have evaluable or measurable disease. MedDRA version: 14.1 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 Name: CDK inhibitor
Product Code: BAY 1000394, 2.5 mg tablet
Pharmaceutical Form: Tablet
Current Sponsor code: BAY 1000394
Other descriptive name: CDK inhibitor
Concentration unit: mg milligra
Sponsors
Bayer Healthcare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female subjects aged equal or above 18 years • Histologically or cytologically confirmed, extensive disease SCLC • At least 1 solid tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1. Subjects with non-measurable disease according to RECIST 1.1 can be included in the Phase Ib part of the study • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 • Life expectancy of at least 12 weeks • Serum sodium equal or above 130 mmol/L 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: • Prior systemic anticancer therapy • Prior radiotherapy (local palliative radiotherapy is permitted) • History of cardiac disease: congestive heart failure > NYHA Class II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months prior to study entry), myocardial infarction within the past 3 months prior to study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) • Moderate or severe hepatic impairment, ie Child-Pugh class B or C • Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1b: Safety, tolerability, pharmacokinetics, and maximum tolerated dose of BAY 1000394 in combination with cisplatin / etoposide or carboplatin / etoposide chemotherapy. Phase II: Response rate in subjects with extensive disease SCLC receiving first-line cisplatin / etoposide or carboplatin / etoposide chemotherapy in combination with BAY 1000394. ;Primary end point(s): Phase 1b: Safety Phase 2: Response Rate;Timepoint(s) of evaluation of this end point: Phase 1b: 30 days after last treatment Phase 2: progression disease or death;Secondary Objective: Phase 1b: Biomarker response profile of BAY 1000394, overall survival, progression-free survival, response rate, duration of response, stable disease and disease control rate. Phase II: tolerability, safety profile, biomarker response profile of BAY 1000394, overall survival, progression-free survival, duration of response, and stable disease and disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 1b: Response Rate ;Timepoint(s) of evaluation of this end point: Phase 1b: progression disease or death | — |
Countries
France, Korea, Republic of, United States
Contacts
Public ContactCTP Team / Ref: "EU CTR" / S102 - R
Bayer Healthcare AG
Outcome results
None listed