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:

NCT01573338

EudraCT Number:

2011-004155-39

Terminated/Withdrawn

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
43
Trial Dates
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Phase
1/2
Could I receive a placebo?
No
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

St. Louis, United States, 63110

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 03080

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 03722

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

Buffalo, United States, 14263-0001

Status
Completed
 
Locations

Investigative Site

VILLEJUIF CEDEX, France, 94805

Status
Completed
 
Locations

Investigative Site

MARSEILLE, France, 13005

Status
Completed
 
Locations

Investigative Site

CAEN CEDEX, France, 14033

Status
Completed
 

Trial Design