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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Torino, Italy, 10043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monza-Brianza, Italy, 20900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sondrio, Italy, 23035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 120-752 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seongnam-si, South Korea, 463-707 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63110-1093 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37232 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boca Raton, United States, 33486 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charleston, United States, 29425 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Grosshansdorf, Germany, 22927 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45147 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torokbalint, Hungary, 2045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matrahaza, Hungary, 3233 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Marseille Cedex 20, France, 13915 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BREST, France, 29285 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE CEDEX, France, 59020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gdansk, Poland, 80-952 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szczecin-Zdunowo, Poland, 70-891 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02-781 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hershey, United States, 17033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15232 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Port St. Lucie, United States, 34952 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kurume, Japan, 830-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo, Japan, 113-8677 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 05505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oldenburg, Germany, 26121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double blind, placebo-controlled, multicenter phase II study to evaluate efficacy and safety of roniciclib in subjects with extensive-stage disease small cell lung cancer (SCLC) who are receiving cisplatin + etoposide or carboplatin + etoposide as first-line therapy
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Progression free survival (PFS)Timeframe: Up to 17 months
Secondary Outcome
- Overall survival (OS)Timeframe: Up to 17 months
- Time to progression (TTP)Timeframe: Up to 17 months
- Overall response rate (ORR)Timeframe: Up to 17 months
Additional Information
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