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

June 20, 2018 updated by: Bayer

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

Terminated

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bruxelles - Brussel, Belgium, 1200
      • Liege, Belgium, 4000
      • Brest, France, 29285
      • Lille Cedex, France, 59020
      • Marseille Cedex 20, France, 13915
      • Paris, France, 75020
      • Grosshansdorf, Germany, 22927
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69126
    • Niedersachsen
      • Oldenburg, Niedersachsen, Germany, 26121
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
      • Budapest, Hungary, 1121
      • Matrahaza, Hungary, 3233
      • Torokbalint, Hungary, 2045
    • Liguria
      • Genova, Liguria, Italy, 16132
    • Lombardia
      • Monza-Brianza, Lombardia, Italy, 20900
      • Sondrio, Lombardia, Italy, 23035
    • Piemonte
      • Torino, Piemonte, Italy, 10043
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8677
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 05505
    • Gyeonggido
      • Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
      • Gdansk, Poland, 80-952
      • Szczecin-Zdunowo, Poland, 70-891
      • Warszawa, Poland, 02-781
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Port Saint Lucie, Florida, United States, 34952
    • Missouri
      • Saint Louis, Missouri, United States, 63110-1093
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Pittsburgh, Pennsylvania, United States, 15232
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: Up to 17 months
Up to 17 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to 17 months
Up to 17 months
Time to progression (TTP)
Time Frame: Up to 17 months
Up to 17 months
Overall response rate (ORR)
Time Frame: Up to 17 months
Up to 17 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2014

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

May 25, 2016

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

June 1, 2018

More Information

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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