Overview

This trial is active, not recruiting.

Condition extensive-stage small-cell lung cancer
Treatments carfilzomib, carboplatin, etoposide
Phase phase 1/phase 2
Target proteasome
Sponsor Onyx Therapeutics, Inc.
Start date September 2013
End date November 2016
Trial size 32 participants
Trial identifier NCT01987232, 2013-002597-44, CFZ004

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Carfilzomib (3 + 3 dose escalation scheme: Days 2, 3, 9, 10 of each 21-day cycle) + Carboplatin (target AUC = 5: Day 1 of each 21-day cycle) + Etoposide (100 mg/m2: Days 1, 2, 3 of each 21-day cycle)
carfilzomib PR-171
carboplatin
etoposide
(Active Comparator)
Carboplatin (target AUC = 5: Day 1 of each 21-day cycle) + Etoposide (100 mg/m2: Days 1, 2, 3 of each 21 -day cycle)
carboplatin
etoposide

Primary Outcomes

Measure
Maximum Tolerated Dose (MTD) - Phase 1b
time frame: First 21-day Cycle
Progression-free Survival (PFS) - Phase 2
time frame: 24 months after the first subject is randomized

Secondary Outcomes

Measure
Best Overall Response (BOR) - Phase 1b & Phase 2
time frame: 24 months after the first subject is randomized
Duration of Response (DOR) - Phase 1b & Phase 2
time frame: 24 months after the first subject is randomized
Overall Survival (OS) - Phase 2
time frame: 30 months after the first subject is randomized
Adverse Events - Phase 1b & Phase 2
time frame: 24 months after the first subject is randomized
Maximum Plasma Concentration - Phase 2
time frame: Cycle 1 Day 2
Time of Maximum Plasma Concentration - Phase 2
time frame: Cycle 1 Day 2
Area Under Plasma Concentration-Time Curve - Phase 2
time frame: Cycle 1 Day 2

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Onyx Pharmaceuticals.