Clinical trial NCT01987232: Phase 1b/2 Study of Carfilzomib, Carboplatin, and Etoposide in Patients With Previously Untreated Extensive Stage Small-cell Lung Cancer
Official title: Phase 1b/2, Multicenter, Open-label Study of Carfilzomib, Carboplatin, and Etoposide in Subjects With Previously Untreated Extensive-stage Small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Extensive-Stage Small-Cell Lung Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-11-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicities
timeFrame: First 21-day Cycle
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first day of any study treatment (i.e., carfilzomib, carboplatin, or etoposide) up to 30 days after the last day of study treatment. The median overall duration of treatment was 16 weeks.
measure: Overall Survival (OS) - Phase 2
timeFrame: 30 months
measure: Maximum Plasma Concentration - Phase 2
timeFrame: Cycle 1 Day 2
measure: Time of Maximum Plasma Concentration - Phase 2
timeFrame: Cycle 1 Day 2
measure: Area Under Plasma Concentration-Time Curve - Phase 2
timeFrame: Cycle 1 Day 2
Other outcomes:
measure: Progression-free Survival
timeFrame: From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.
measure: Overall Response Rate
timeFrame: From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.
measure: Duration of Response
timeFrame: From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.
Locations:
city: New Haven
country: United States
facility: Yale University, Yale Cancer Center
state: Connecticut
city: Gainesville
country: United States
facility: UF Health Davis Cancer Pavilion and Shands Med Plaza
state: Florida
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Research, Inc.
state: Indiana
city: Muncie
country: United States
facility: Indiana University Health Ball Memorial Hospital
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington Clinical Research Center
state: Kentucky
city: Frederick
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack UMC
state: New Jersey
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kislino
country: Russian Federation
facility: Regional Budgetary Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"
state: Kursk
city: Arkhangelsk
country: Russian Federation
facility: State budgetary healthcare institution of Arkhangelsk Region "Arkhangelsk Clinical Oncological Dispensary"
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "N.N. Blokhin Russian Cancer Research Center"
city: St. Petersburg
country: Russian Federation
facility: State Budgetary Educational Inslitution of Higher Professional Education "First St. Petersburg I.P.Pavlov State Medical University"
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncological Hospital"
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: