Trial Condition(s):
Small Cell Lung Carcinoma
Clinical study to evaluate the maximum tolerated dose of BAY1000394 when given together with chemotherapy and the effectiveness of this combination treatment in shrinking a specific type of lung tumors (small cell lung cancer)
Bayer Identifier:
14858
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Different groups of patients will receive different dosages of BAY1000394 to determine the safety and maximum tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of chemotherapy is the standard dose usually administered and will not change.
The study will also assess how the drug is metabolized by the body and changes in tumor size.
BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will stop if the tumor continues to grow, if side effects occur which the patient can not tolerate or if the patients decides to exit treatment.
Inclusion Criteria
- Male or female subjects aged >/=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 >/=130 mmol/L
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), any episodes of angina or history of myocardial infarction, cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), previous venous or arterial thrombotic events, pulmonary embolism - Moderate or severe hepatic impairment, ie Child-Pugh class B or C - Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site St. Louis, United States, 63110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03722 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44195 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buffalo, United States, 14263-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VILLEJUIF CEDEX, France, 94805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CAEN CEDEX, France, 14033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse events collectionTimeframe: up to 3 years
- tumor response - number of subjects with best tumor response that is achieved during or within 30 days after end of therapyTimeframe: up to 3 years
- Maximum Tolerated Dose (MTD) - measured by adverse event profile at the end of Cycle 1. MTD will be the highest dose level achieved during dose escalation where non or 1 of 6 subjects experience a dose limiting toxicity as defined in the protocolTimeframe: up to 3 years
- Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394Timeframe: Cycle 1, Day 8 and Cycle 2, Day 1
- Area under the concentration versus time curve from zero to infinity after single (first) dose(AUC) of BAY1000394Timeframe: Cycle 1, Day 8 and Cycle 2, Day 1
Secondary Outcome
- Disease control rate (DCR)number of patients with complete response, partial response or stable disease according to RECISTTimeframe: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
- Overall survival (OS)time (days) from date of first treatment to death due to any cause.Timeframe: From start of treatment of the first subject until 3 years later
- Time to progression (TTP)time (days) from date of first treatment to first observed radiological disease progressionTimeframe: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
- Progression-free survival (PFS)time (days) from date of first treatment to first observed radiological disease progression or deathTimeframe: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
- Duration of response (DOR)time (days) from date of first radiological response to the date that progressive disease is first radiologically documented or death occursTimeframe: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
- Stable disease (SD)time (days) from date of first treatment to first observed radiological disease progression or deathTimeframe: From start of treatment of the first subject until 3 years later, assessed every 6 weeks
Additional Information
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