RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer

Last updated: June 20, 2018
Sponsor: Bayer
Overall Status: Terminated

Phase

2

Condition

Small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT02161419
14615
2013-004198-28
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 (smallcell lung cancer)

  • At least 1 solid tumor lesion measurable by computer tomography (CT) scan or magneticresonance 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

Exclusion Criteria:

  • Prior systemic anticancer therapy for SCLC (including previous therapy with acyclin-dependent kinase [CDK] inhibitor)

Study Design

Total Participants: 142
Study Start date:
July 30, 2014
Estimated Completion Date:
May 25, 2016

Connect with a study center

  • Bruxelles - Brussel, 1200
    Belgium

    Site Not Available

  • Liege, 4000
    Belgium

    Site Not Available

  • empty

    Namur, 5000
    Belgium

    Site Not Available

  • Brest, 29285
    France

    Site Not Available

  • Lille Cedex, 59020
    France

    Site Not Available

  • Marseille Cedex 20, 13915
    France

    Site Not Available

  • Paris, 75020
    France

    Site Not Available

  • Heidelberg, Baden-Württemberg 69126
    Germany

    Site Not Available

  • Oldenburg, Niedersachsen 26121
    Germany

    Site Not Available

  • Essen, Nordrhein-Westfalen 45147
    Germany

    Site Not Available

  • Grosshansdorf, 22927
    Germany

    Site Not Available

  • Budapest, 1121
    Hungary

    Site Not Available

  • empty

    Gyor, 9024
    Hungary

    Site Not Available

  • Matrahaza, 3233
    Hungary

    Site Not Available

  • Torokbalint, 2045
    Hungary

    Site Not Available

  • Genova, Liguria 16132
    Italy

    Site Not Available

  • Monza-Brianza, Lombardia 20900
    Italy

    Site Not Available

  • Sondrio, Lombardia 23035
    Italy

    Site Not Available

  • empty

    Monza, Monza-Brianza 20052
    Italy

    Site Not Available

  • Torino, Piemonte 10043
    Italy

    Site Not Available

  • empty

    Orbassano, Torino 10043
    Italy

    Site Not Available

  • empty

    Sondalo, 23035
    Italy

    Site Not Available

  • empty

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Kurume, Fukuoka 830-0011
    Japan

    Site Not Available

  • Bunkyo, Tokyo 113-8677
    Japan

    Site Not Available

  • Seongnam-si, Gyeonggido 463-707
    Korea, Republic of

    Site Not Available

  • Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Gdansk, 80-952
    Poland

    Site Not Available

  • empty

    Olsztyn, 10-357
    Poland

    Site Not Available

  • empty

    Poznan, 60-569
    Poland

    Site Not Available

  • empty

    Szczecin, 70-891
    Poland

    Site Not Available

  • Szczecin-Zdunowo, 70-891
    Poland

    Site Not Available

  • Warszawa, 02-781
    Poland

    Site Not Available

  • Boca Raton, Florida 33486
    United States

    Site Not Available

  • Port Saint Lucie, Florida 34952
    United States

    Site Not Available

  • empty

    Port St. Lucie, Florida 34952
    United States

    Site Not Available

  • empty

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Saint Louis, Missouri 63110-1093
    United States

    Site Not Available

  • empty

    St. Louis, Missouri 63110-1093
    United States

    Site Not Available

  • empty

    Rochester, New York 14642
    United States

    Site Not Available

  • Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Charleston, South Carolina 29425
    United States

    Site Not Available

  • Nashville, Tennessee 37232
    United States

    Site Not Available

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