Phase 1b/2 Study of Carfilzomib, Carboplatin, and Etoposide in Subjects With Previously Untreated Extensive Stage Small-cell Lung Cancer
Conditions
Extensive-Stage Small-Cell Lung Cancer
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carfilzomib Type: Drug
Name: Carboplatin Type: Drug
Name: Etoposide Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib given in combination with carboplatin and etoposide as initial therapy for subjects with Extensive-Stage Small-Cell Lung Cancer (ES SCLC).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of extensive-stage small-cell lung cancer (ES-SCLC) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; ES-SCLC is defined as: small-cell lung cancer (SCLC) that has spread beyond one hemithorax and regional lymph nodes on the same side (e.g., supraclavicular) to the contralateral hemithorax, lymph nodes, or more distant locations in the body

2. Subjects with asymptomatic brain metastases or other central nervous system (CNS) disease at screening/diagnosis are eligible

3. Males and females ≥ 18 years of age

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Key Exclusion Criteria:

1. Previous systemic therapy to treat small-cell lung cancer (SCLC). Subjects with recurrent or progressive limited-stage SCLC after previous systemic treatment are not eligible for study participation.

2. Whole brain or focal radiation therapy within 14 days prior to Cycle 1 Day 1 (C1D1) for Phase 1b or prior to randomization for Phase 2

3. Congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to prior to C1D1 for Phase 1b or prior to randomization for Phase 2
Locations
Yale University, Yale Cancer Center
New Haven, Connecticut, United States
Status: Recruiting
UF Health Davis Cancer Pavilion and Shands Med Plaza
Gainesville, Florida, United States
Status: Recruiting
Goshen Center for Cancer Care
Goshen, Indiana, United States
Status: Recruiting
Horizon Oncology Research, Inc.
Lafayette, Indiana, United States
Status: Recruiting
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, United States
Status: Recruiting
Baptist Health Lexington Clinical Research Center
Lexington, Kentucky, United States
Status: Recruiting
Frederick Memorial Hospital
Frederick, Maryland, United States
Status: Recruiting
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Status: Recruiting
Levine Cancer Institute
Charlotte, North Carolina, United States
Status: Recruiting
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Status: Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Regional Budgetary Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"
Kislino, Kursk, Russian Federation
Status: Recruiting
State budgetary healthcare institution of Arkhangelsk Region "Arkhangelsk Clinical Oncological Dispensary"
Arkhangelsk, Russian Federation
Status: Recruiting
Federal State Budgetary Scientific Institution "N.N. Blokhin Russian Cancer Research Center"
Moscow, Russian Federation
Status: Recruiting
State Budgetary Educational Inslitution of Higher Professional Education "First St. Petersburg I.P.Pavlov State Medical University"
St. Petersburg, Russian Federation
Status: Recruiting
State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncological Hospital"
Yaroslavl, Russian Federation
Status: Recruiting
Start Date
September 2013
Completion Date
September 2017
Sponsors
Onyx Therapeutics, Inc.
Source
Onyx Pharmaceuticals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page