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

Small Cell Lung Carcinoma Clinical Trial

— CONCEPT-SCLC  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02161419
• Other study ID #: 14615
• Secondary ID: 2013-004198-28
• Status: Terminated
• Phase: Phase 2
• Start date: July 30, 2014
• Est. completion date: May 25, 2016

Study information

• Verified date: June 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: May 25, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		Up to 17 months
Secondary	Overall survival (OS)		Up to 17 months
Secondary	Time to progression (TTP)		Up to 17 months
Secondary	Overall response rate (ORR)		Up to 17 months

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