RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer
Public ClinicalTrials.gov record NCT02161419. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02161419
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 142 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 29, 2014
- Primary completion
- Dec 30, 2015
- Completion
- May 24, 2016
- Last update posted
- Jun 24, 2018
2014 – 2016
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Boca Raton | Florida | 33486 | — |
| Not listed | Port Saint Lucie | Florida | 34952 | — |
| Not listed | St Louis | Missouri | 63110-1093 | — |
| Not listed | Hershey | Pennsylvania | 17033 | — |
| Not listed | Pittsburgh | Pennsylvania | 15232 | — |
| Not listed | Charleston | South Carolina | 29425 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02161419, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 24, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02161419 live on ClinicalTrials.gov.