stop_circleTerminated/Withdrawn

Small Cell Lung Carcinoma

Bayer Identifier:

14615

ClinicalTrials.gov Identifier:

NCT02161419

EudraCT Number:

2013-004198-28

EU CT Number:

Not Available
RONICICLIB / Placebo in combination with chemotherapy in Small Cell Lung Cancer

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

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

Trial summary

Enrollment Goal
142
Trial Dates
July 2014 - May 2016
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Torino, 10043, Italy
Completed
Monza-Brianza, 20900, Italy
Completed
Genova, 16132, Italy
Completed
Sondrio, 23035, Italy
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Withdrawn
Seoul, 03080, Korea, Republic Of
Completed
Seoul, 120-752, Korea, Republic Of
Completed
Seongnam-si, 463-707, Korea, Republic Of
Completed
St. Louis, 63110-1093, United States
Completed
Nashville, 37232, United States
Withdrawn
Chicago, 60611, United States
Withdrawn
Rochester, 14642, United States
Completed
Boca Raton, 33486, United States
Completed
Charleston, 29425, United States
Completed
LIEGE, 4000, Belgium
Completed
Grosshansdorf, 22927, Germany
Completed
Essen, 45147, Germany
Completed
Heidelberg, 69126, Germany
Completed
Budapest, 1121, Hungary
Completed
Torokbalint, 2045, Hungary
Completed
Matrahaza, 3233, Hungary
Withdrawn
Gyor, 9024, Hungary
Completed
Marseille Cedex 20, 13915, France
Completed
PARIS, 75020, France
Completed
BREST, 29285, France
Completed
LILLE CEDEX, 59020, France
Completed
Gdansk, 80-952, Poland
Completed
Szczecin-Zdunowo, 70-891, Poland
Completed
Warszawa, 02-781, Poland
Completed
Hershey, 17033, United States
Completed
Pittsburgh, 15232, United States
Completed
Port St. Lucie, 34952, United States
Withdrawn
NAMUR, 5000, Belgium
Withdrawn
Kashiwa, 277-8577, Japan
Completed
Kurume, 830-0011, Japan
Completed
Bunkyo, 113-8677, Japan
Completed
Seoul, 05505, Korea, Republic Of
Completed
Oldenburg, 26121, Germany
Withdrawn
Poznan, 60-569, Poland

Primary Outcome

  • Progression free survival (PFS)
    date_rangeTime Frame:
    Up to 17 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall survival (OS)
    date_rangeTime Frame:
    Up to 17 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to progression (TTP)
    date_rangeTime Frame:
    Up to 17 months
    enhanced_encryption
    Safety Issue:
    No
  • Overall response rate (ORR)
    date_rangeTime Frame:
    Up to 17 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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