CompletedPhase 1 / Phase 2NCT01987232

Phase 1b/2 Study of Carfilzomib, Carboplatin, and Etoposide in Patients With Previously Untreated Extensive Stage Small-cell Lung Cancer

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 patients with extensive-stage small-cell lung cancer (ES SCLC).

Checked against the public recordLast updated Aug 28, 2017 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations17
SponsorAmgen
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Amgen
Interventions being studied
Drug: Carfilzomib; Drug: Carboplatin; Drug: Etoposide
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Yale University, Yale Cancer CenterNew Haven, Connecticut
  • UF Health Davis Cancer Pavilion and Shands Med PlazaGainesville, Florida
  • Goshen Center for Cancer CareGoshen, Indiana
  • Horizon Oncology Research, Inc.Lafayette, Indiana
  • Indiana University Health Ball Memorial HospitalMuncie, Indiana
  • Baptist Health Lexington Clinical Research CenterLexington, Kentucky
  • Frederick Memorial HospitalFrederick, Maryland
  • John Theurer Cancer Center at Hackensack UMCHackensack, New Jersey
  • Levine Cancer InstituteCharlotte, North Carolina
  • Wake Forest Baptist HealthWinston-Salem, North Carolina
  • The University of Texas MD Anderson Cancer CenterHouston, Texas
  • Juravinski Cancer CentreHamilton, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 28, 2017. Always confirm current availability with the study team.

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