Overview

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

Status:
Completed
Trial end date:
2017-05-04
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Onyx Therapeutics, Inc.
Treatments:
Carboplatin
Etoposide
Etoposide phosphate
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