Untreated extensive stage small cell lung cancer MedDRA version: 18.1 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Kyprolis
Product Name: Carfilzomib
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: CARFILZOMIB
Sponsors
Onyx Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1b: To determine the maximum tolerated dose (MTD) of carfilzomib given in combination with standard dose carboplatin (target AUC [area under the curve] = 5, the maximum dose is 5 × 150 = 750 mg; intravenous [IV]) on Day 1 and etoposide (also known as VP-16;100 mg/m2; IV) on Days 1, 2, and 3 every 3 weeks as treatment for previously untreated extensive-stage small-cell lung cancer (ES-SCLC). Phase 2: To evaluate the efficacy of carfilzomib with carboplatin and etoposide (carfilzomib combination arm) versus carboplatin and etoposide alone (control arm) in subjects with treatment-naïve ES-SCLC, as measured by progression-free survival (PFS) ; Secondary Objective: Phase 1b: To evaluate the safety and tolerability of the carfilzomib, carboplatin, and etoposide combination. Phase 2: carfilzomib combination arm versus the control arm - To assess duration of response (DOR) in the carfilzomib combination arm and the control arm - To evaluate efficacy as measured by overall survival (OS) in the carfilzomib combination arm versus the control arm - To evaluate the safety and tolerability of the carfilzomib combination arm and the control arm - To assess the pharmacokinetics (PK) of carfilzomib when given in combination with carboplatin and etoposide ; Primary end point(s): Phase 1b: Maximum tolerated dose (MTD) Phase 2: Progression free survival (PFS) ; Timepoint(s) of evaluation of this end point: Phase 1b: The (Maximum Tolerated Dose) MTD is defined as the highest dose level at which < 33% of subjects experience a (Dose limiting toxicity) DLT during the first 21-day cycle. Phase 2: PFS (progression free survival), defined as time from randomization to PD (progressive disease) or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 2 -Best overall response (BOR) -Duration of response (DOR) -Overall survival (OS) -Safety and tolerability -Pharmacokinetics (PK) ; Timepoint(s) of evaluation of this end point: Phase 2 -Best overall response (BOR): Defined as either confirmed CR or PR per RECIST Version 1.1. -Duration of response (DOR): Defined as the time from first evidence of PR or better to documented PD or death due to any cause -Overall survival (OS): Defined as the time from randomization to the date of death (this endpoint is for Phase 2 only) -Safety and tolerability - The safety population includes all subjects who receive at least one dose of study treatment. -Pharmacokinetics (PK) - All PK parameters will be computed using actual elapsed time calculated relative to the start of dose administration. | — |
Countries
Canada, France, Germany, Hungary, Russian Federation, United Kingdom, United States
Contacts
Public ContactIHQ medical Info-Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed