NCT02161419

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2014-07-30
• Primary completion: 2015-12-31
• Completion: 2016-05-25
• First posted: 2014-06-11
• Last updated: 2018-06-25

Locations

32 sites across 9 countries: United States, Belgium, France, Germany, Hungary, Italy, Japan, Poland, South Korea