- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02161419
RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer (CONCEPT-SCLC)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Bruxelles - Brussel, Belgium, 1200
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Liege, Belgium, 4000
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Brest, France, 29285
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Lille Cedex, France, 59020
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Marseille Cedex 20, France, 13915
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Paris, France, 75020
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Grosshansdorf, Germany, 22927
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germany, 69126
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Niedersachsen
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Oldenburg, Niedersachsen, Germany, 26121
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, Germany, 45147
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Budapest, Hungary, 1121
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Matrahaza, Hungary, 3233
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Torokbalint, Hungary, 2045
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Liguria
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Genova, Liguria, Italy, 16132
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Lombardia
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Monza-Brianza, Lombardia, Italy, 20900
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Sondrio, Lombardia, Italy, 23035
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Piemonte
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Torino, Piemonte, Italy, 10043
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Fukuoka
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Kurume, Fukuoka, Japan, 830-0011
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Tokyo
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Bunkyo, Tokyo, Japan, 113-8677
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 05505
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Gyeonggido
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Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
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Gdansk, Poland, 80-952
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Szczecin-Zdunowo, Poland, 70-891
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Warszawa, Poland, 02-781
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Florida
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Boca Raton, Florida, United States, 33486
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Port Saint Lucie, Florida, United States, 34952
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Missouri
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Saint Louis, Missouri, United States, 63110-1093
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
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Pittsburgh, Pennsylvania, United States, 15232
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South Carolina
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Charleston, South Carolina, United States, 29425
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Tennessee
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Nashville, Tennessee, United States, 37232
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: BAY1000394
Roniciclib 5 mg bid 3 days on / 4 days off in combination with chemotherapy (carboplatin/etoposide or cisplatin/etoposide) during 6 cycles (21 days each) followed by monotherapy
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Patients will receive roniciclib treatment as a 3 days on / 4 days schedule off with two 2.5 mg tablets twice daily for a total dose of 10.0 mg/day during 6 cycles (21 days each) of chemotherapy with Carboplatin/etoposide or Cisplatin/etoposide and continue thereafter as monotherapy until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study.
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Placebo Comparator: Placebo
Matching placebo 3 days on / 4 days off in combination with chemotherapy (carboplatin/etoposide or cisplatin/etoposide) during 6 cycles (21 days each) followed by monotherapy
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Patients will receive placebo treatment as a 3 days on / 4 days schedule off with two tablets twice daily during 6 cycles (21 days each) of chemotherapy with Carboplatin/etoposide or Cisplatin/etoposide and continue thereafter as monotherapy until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Progression free survival (PFS)
Time Frame: Up to 17 months
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Up to 17 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival (OS)
Time Frame: Up to 17 months
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Up to 17 months
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Time to progression (TTP)
Time Frame: Up to 17 months
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Up to 17 months
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Overall response rate (ORR)
Time Frame: Up to 17 months
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Up to 17 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14615
- 2013-004198-28 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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