Phase Ib / II study of BAY 1000394 in combination with cisplatin / etoposide or carboplatin / etoposide as first-line therapy in subjects with extensive disease small cell lung cancer

Phase 1

Conditions: 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: 14.1Level: 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: EUCTR2011-004155-39-FR

Lead Sponsor: Bayer Healthcare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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

• 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase 1b: Safety, tolerability, pharmacokinetics, and maximum tolerated dose of BAY 1000394 in combination with cisplatin / etoposide or carboplatin / etoposide chemotherapy.<br><br>Phase II: Response rate in subjects with extensive disease SCLC receiving first-line cisplatin / etoposide or carboplatin / etoposide chemotherapy in combination with BAY 1000394.<br>;Primary end point(s): Phase 1b: Safety<br>Phase 2: Response Rate;Timepoint(s) of evaluation of this end point: Phase 1b: 30 days after last treatment<br>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.<br><br>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 Outcome Measures