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RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer (CONCEPT-SCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161419
Recruitment Status : Terminated
First Posted : June 11, 2014
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment Phase
Small Cell Lung Carcinoma Drug: Roniciclib (BAY1000394) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 30, 2014
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : May 25, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Roniciclib (BAY1000394)
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.

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
Drug: Placebo
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




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Up to 17 months ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 17 months ]
  2. Time to progression (TTP) [ Time Frame: Up to 17 months ]
  3. Overall response rate (ORR) [ Time Frame: Up to 17 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161419


Locations
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United States, Florida
Boca Raton, Florida, United States, 33486
Port Saint Lucie, Florida, United States, 34952
United States, Missouri
Saint Louis, Missouri, United States, 63110-1093
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Nashville, Tennessee, United States, 37232
Belgium
Bruxelles - Brussel, Belgium, 1200
Liege, Belgium, 4000
France
Brest, France, 29285
Lille Cedex, France, 59020
Marseille Cedex 20, France, 13915
Paris, France, 75020
Germany
Heidelberg, Baden-Württemberg, Germany, 69126
Oldenburg, Niedersachsen, Germany, 26121
Essen, Nordrhein-Westfalen, Germany, 45147
Grosshansdorf, Germany, 22927
Hungary
Budapest, Hungary, 1121
Matrahaza, Hungary, 3233
Torokbalint, Hungary, 2045
Italy
Genova, Liguria, Italy, 16132
Monza-Brianza, Lombardia, Italy, 20900
Sondrio, Lombardia, Italy, 23035
Torino, Piemonte, Italy, 10043
Japan
Kurume, Fukuoka, Japan, 830-0011
Bunkyo, Tokyo, Japan, 113-8677
Korea, Republic of
Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 120-752
Poland
Gdansk, Poland, 80-952
Szczecin-Zdunowo, Poland, 70-891
Warszawa, Poland, 02-781
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02161419    
Other Study ID Numbers: 14615
2013-004198-28 ( EudraCT Number )
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Keywords provided by Bayer:
Small Cell Lung Carcinoma,
First line
Extensive disease
Small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms