Trial Condition(s):

Small Cell Lung Carcinoma

RONICICLIB / Placebo in combination with chemotherapy in Small Cell Lung Cancer (CONCEPT-SCLC)

Bayer Identifier:

14615

ClinicalTrials.gov Identifier:

NCT02161419

EudraCT Number:

2013-004198-28

Terminated/Withdrawn

Trial Purpose

This is a study to investigate the potential clinical benefit of roniciclib when given in combination with chemotherapy Carboplatin / Etoposide or Cisplatin / Etoposide as first line treatment in patients with extensive disease small cell lung cancer. Approximately 140 patients will be randomized (1:1) to receive treatment with either roniciclib or placebo in combination with chemotherapy.
Roniciclib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. The growth of the tumor may be decreased by preventing these specific proteins from functioning. By specifically targeting these proteins, roniciclib in combination with chemotherapy may stop cancer growth.
The primary endpoint (the most meaningful result to be tracked) of this study is based on the progression free survival, i.e. the time the disease is not worsening. The aim is to show that the therapy with roniciclib in combination with chemotherapy prolongs the time the disease is not worsening in this patient population compared to patients receiving placebo in combination with chemotherapy.

Inclusion Criteria
- Male or female subjects aged ≥18 years (or country-specific legal age of maturity, if >18 years)
 - Histologically or cytologically confirmed  (extensive-stage disease) ED SCLC (small cell lung cancer)
 - At least 1 solid tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 
 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
Exclusion Criteria
- Prior systemic anticancer therapy for SCLC (including previous therapy with a cyclin-dependent kinase [CDK] inhibitor)

Trial Summary

Enrollment Goal
142
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Torino, Italy, 10043

Status
Completed
 
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Investigative Site

Monza-Brianza, Italy, 20900

Status
Completed
 
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Investigative Site

Genova, Italy, 16132

Status
Completed
 
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Investigative Site

Sondrio, Italy, 23035

Status
Completed
 
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Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
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Investigative Site

Seoul, South Korea, 120-752

Status
Completed
 
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Investigative Site

Seongnam-si, South Korea, 463-707

Status
Completed
 
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Investigative Site

St. Louis, United States, 63110-1093

Status
Completed
 
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Investigative Site

Nashville, United States, 37232

Status
Completed
 
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Investigative Site

Boca Raton, United States, 33486

Status
Completed
 
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Investigative Site

Charleston, United States, 29425

Status
Completed
 
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Investigative Site

LIEGE, Belgium, 4000

Status
Completed
 
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Investigative Site

Grosshansdorf, Germany, 22927

Status
Completed
 
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Investigative Site

Essen, Germany, 45147

Status
Completed
 
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Investigative Site

Heidelberg, Germany, 69126

Status
Completed
 
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Investigative Site

Budapest, Hungary, 1121

Status
Completed
 
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Investigative Site

Torokbalint, Hungary, 2045

Status
Completed
 
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Investigative Site

Matrahaza, Hungary, 3233

Status
Completed
 
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Investigative Site

Marseille Cedex 20, France, 13915

Status
Completed
 
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Investigative Site

PARIS, France, 75020

Status
Completed
 
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Investigative Site

BREST, France, 29285

Status
Completed
 
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Investigative Site

LILLE CEDEX, France, 59020

Status
Completed
 
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Investigative Site

Gdansk, Poland, 80-952

Status
Completed
 
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Investigative Site

Szczecin-Zdunowo, Poland, 70-891

Status
Completed
 
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Investigative Site

Warszawa, Poland, 02-781

Status
Completed
 
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Investigative Site

Hershey, United States, 17033

Status
Completed
 
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Investigative Site

Pittsburgh, United States, 15232

Status
Completed
 
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Investigative Site

Port St. Lucie, United States, 34952

Status
Completed
 
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Investigative Site

Kurume, Japan, 830-0011

Status
Completed
 
Locations

Investigative Site

Bunkyo, Japan, 113-8677

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 05505

Status
Completed
 
Locations

Investigative Site

Oldenburg, Germany, 26121

Status
Completed
 

Trial Design