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Clinical Trial VICCTHO1444

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

Principal Investigator(s)

Leora Horn

Details

  • Protocol No. VICCTHO1444
  • Open Date: 08/05/2014
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objective is to compare roniciclib with placebo in addition to background treatment with chemotherapy (either cisplatin + etoposide or carboplatin + etoposide) in terms of progression free survival (PFS) in SCLC patients.
  • Disease Sites: Lung
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Carboplatin; Cisplatin; Etoposide; Roniciclib
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02161419
  • Secondary Protocol No: BAY 1000394/14615

Description

Patients are being asked to take part in this research study because they have been diagnosed with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if the study drug roniciclib is effective and safe when given in combination with the chemotherapy drugs cisplatin plus etoposide, or carboplatin plus etoposide, as the first therapy in extensive disease small cell lung cancer. Roniciclib is an investigational drug that is not approved by the U.S. Food and Drug Administration (FDA), nor available for sale in any country outside of the United States. Roniciclib is an oral drug taken by mouth. In this study, patients will receive a standard chemotherapy treatment that is recommended for their kind of cancer, and which is selected by their study doctor: Either cisplatin + etoposide OR carboplatin + etoposide. In addition to chemotherapy, patients will also receive either the roniciclib study drug, or a placebo. In the hand, the placebo looks just like the roniciclib study drug, but the placebo pills do not contain roniciclib. Thus, the placebo has no treatment activity. All patients in this study will receive chemotherapy appropriate for their disease. But a computer program will be used to decide if patients will additionally receive either the roniciclib study drug, or a placebo. Patients have a 1 in 2 (50%) chance, like the flip of a coin, to receive the study drug roniciclib or placebo. Thus, the combination chemotherapy (either cisplatin + etoposide OR carboplatin + etoposide) together with roniciclib or placebo will be the study treatment.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

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)