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
2 other identifiers
interventional
142
9 countries
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2014
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 11, 2014
CompletedStudy Start
First participant enrolled
July 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2016
CompletedJune 25, 2018
June 1, 2018
1.4 years
June 10, 2014
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
Up to 17 months
Secondary Outcomes (3)
Overall survival (OS)
Up to 17 months
Time to progression (TTP)
Up to 17 months
Overall response rate (ORR)
Up to 17 months
Study Arms (2)
BAY1000394
ACTIVE COMPARATORRoniciclib 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
Placebo
PLACEBO COMPARATORMatching 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
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior systemic anticancer therapy for SCLC (including previous therapy with a cyclin-dependent kinase \[CDK\] inhibitor)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (32)
Unknown Facility
Boca Raton, Florida, 33486, United States
Unknown Facility
Port Saint Lucie, Florida, 34952, United States
Unknown Facility
St Louis, Missouri, 63110-1093, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15232, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Bruxelles - Brussel, 1200, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Brest, 29285, France
Unknown Facility
Lille, 59020, France
Unknown Facility
Marseille, 13915, France
Unknown Facility
Paris, 75020, France
Unknown Facility
Heidelberg, Baden-Wurttemberg, 69126, Germany
Unknown Facility
Oldenburg, Lower Saxony, 26121, Germany
Unknown Facility
Essen, North Rhine-Westphalia, 45147, Germany
Unknown Facility
Großhansdorf, 22927, Germany
Unknown Facility
Budapest, 1121, Hungary
Unknown Facility
Mátraháza, 3233, Hungary
Unknown Facility
Törökbálint, 2045, Hungary
Unknown Facility
Genoa, Liguria, 16132, Italy
Unknown Facility
Monza-Brianza, Lombardy, 20900, Italy
Unknown Facility
Sondrio, Lombardy, 23035, Italy
Unknown Facility
Turin, Piedmont, 10043, Italy
Unknown Facility
Kurume, Fukuoka, 830-0011, Japan
Unknown Facility
Bunkyo, Tokyo, 113-8677, Japan
Unknown Facility
Gdansk, 80-952, Poland
Unknown Facility
Szczecin-Zdunowo, 70-891, Poland
Unknown Facility
Warsaw, 02-781, Poland
Unknown Facility
Seongnam-si, Gyeonggido, 463-707, South Korea
Unknown Facility
Seoul, 05505, South Korea
Unknown Facility
Seoul, 120-752, South Korea
Related Publications (1)
Reck M, Horn L, Novello S, Barlesi F, Albert I, Juhasz E, Kowalski D, Robinet G, Cadranel J, Bidoli P, Chung J, Fritsch A, Drews U, Wagner A, Govindan R. Phase II Study of Roniciclib in Combination with Cisplatin/Etoposide or Carboplatin/Etoposide as First-Line Therapy in Patients with Extensive-Disease Small Cell Lung Cancer. J Thorac Oncol. 2019 Apr;14(4):701-711. doi: 10.1016/j.jtho.2019.01.010. Epub 2019 Jan 21.
PMID: 30677506DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 11, 2014
Study Start
July 30, 2014
Primary Completion
December 31, 2015
Study Completion
May 25, 2016
Last Updated
June 25, 2018
Record last verified: 2018-06