RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/27/2018 |
| Start Date: | July 30, 2014 |
| End Date: | May 25, 2016 |
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
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.
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.
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)
We found this trial at
8
sites
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