RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer
Conditions
Small Cell Lung Carcinoma
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Conditions: Keywords
Small Cell Lung Carcinoma,, First line, Extensive disease, Small cell lung cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Roniciclib (BAY1000394) Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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)
Locations
Boca Raton, Florida, United States
Status: Recruiting
Port St. Lucie, Florida, United States
Status: Recruiting
Chicago, Illinois, United States
Status: Terminated
St. Louis, Missouri, United States
Status: Recruiting
Rochester, New York, United States
Status: Not yet recruiting
Hershey, Pennsylvania, United States
Status: Recruiting
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Charleston, South Carolina, United States
Status: Recruiting
Nashville, Tennessee, United States
Status: Recruiting
Bruxelles - Brussel, Belgium
Status: Recruiting
Liege, Belgium
Status: Recruiting
Namur, Belgium
Status: Not yet recruiting
Brest, France
Status: Recruiting
Lille Cedex, France
Status: Recruiting
Marseille Cedex 20, France
Status: Recruiting
Paris, France
Status: Recruiting
Heidelberg, Baden-Württemberg, Germany
Status: Recruiting
Essen, Nordrhein-Westfalen, Germany
Status: Recruiting
Grosshansdorf, Germany
Status: Recruiting
Budapest, Hungary
Status: Recruiting
Gyor, Hungary
Status: Not yet recruiting
Matrahaza, Hungary
Status: Recruiting
Torokbalint, Hungary
Status: Recruiting
Monza, Monza-Brianza, Italy
Status: Recruiting
Orbassano, Torino, Italy
Status: Recruiting
Genova, Italy
Status: Recruiting
Sondalo, Italy
Status: Recruiting
Kashiwa, Chiba, Japan
Status: Not yet recruiting
Kurume, Fukuoka, Japan
Status: Recruiting
Bunkyo, Tokyo, Japan
Status: Not yet recruiting
Seongnam-si, Gyeonggido, Korea, Republic of
Status: Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of
Status: Terminated
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Not yet recruiting
Gdansk, Poland
Status: Recruiting
Olsztyn, Poland
Status: Not yet recruiting
Poznan, Poland
Status: Not yet recruiting
Szczecin, Poland
Status: Recruiting
Warszawa, Poland
Status: Recruiting
Start Date
July 2014
Completion Date
March 2017
Sponsors
Bayer
Source
Bayer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page