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NCT02161419 · ClinicalTrials.gov registry record · Phase 2
RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer
A Phase 2 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
NCT02161419 is a Phase 2 study that was terminated before completion, run by Bayer. The registered enrollment target is 142 participants.
The verdict
NCT02161419, a Phase 2 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
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.
Interventions
- DRUG Placebo
- DRUG Roniciclib (BAY1000394)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2014-07-30 |
| Est. Completion | 2016-05-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02161419
The ClinicalTrials.gov registry entry for NCT02161419 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02161419 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02161419 about?
NCT02161419 is a clinical study titled "RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer". 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...
What is the current status of trial NCT02161419?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2014-07-30. Estimated completion is 2016-05-25.
What interventions are being tested in trial NCT02161419?
The interventions under investigation include: Placebo (DRUG), Roniciclib (BAY1000394) (DRUG).
Who is sponsoring clinical trial NCT02161419?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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