RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer (CONCEPT-SCLC)
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| ClinicalTrials.gov Identifier: NCT02161419 |
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Recruitment Status :
Terminated
First Posted : June 11, 2014
Last Update Posted : June 25, 2018
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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 |
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| Small Cell Lung Carcinoma | Drug: Roniciclib (BAY1000394) Drug: Placebo | Phase 2 |
| 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 |
| 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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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. |
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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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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 |
- Progression free survival (PFS) [ Time Frame: Up to 17 months ]
- Overall survival (OS) [ Time Frame: Up to 17 months ]
- Time to progression (TTP) [ Time Frame: Up to 17 months ]
- Overall response rate (ORR) [ Time Frame: Up to 17 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
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
| 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 | |
| Study Director: | Bayer Study Director | Bayer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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Small Cell Lung Carcinoma, First line Extensive disease Small cell lung cancer |
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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 |