Glioblastoma MedDRA version: 18.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: LY2157299 monohydrate
Product Code: LY2157299 monohydrate
Pharmaceutical Form: Tablet
INN or Proposed INN: LY2157299
Current Sponsor code: LY2157299
Other descriptive name: LY2157299
Con
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients at or older than 18 years and who have relapsed Glioblastoma after first-line treatment with chemoradiation, have measureable disease (response to be based on RANO criteria), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: Moderate or severe cardiac condition. Prior treatment with nitrosurea. Prior treatment with bevacizumab as part of a first-line treatment for GB, Serious concomitant systemic disorder, Current acute or chronic myelogenous leukemia, Second primary malignancy, Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall Survival ;Secondary Objective: PK of LY2157299 monohydrate. Evaluate Safety Prognostic and predictive marker assessment Progression-free survival , median OS and PFS, OS and PFS rates at 6 months Tumor response rate Assess patient-reported symptoms and neurocognitive function ;Primary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: Date of randomization to the date of death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression-free survival and PFS rate at 6 months, 9 months, 12 months Median OS and at 6 months Tumor response rate PK of LY2157299 monohydrate. Evaluate Safety (safety parameters are reduced in the continued access period) Prognostic and predictive marker assessment Tumor response rate RANO criteria Change in patient-reported symptoms and neurocognitive function ;Timepoint(s) of evaluation of this end point: PFS - Every 2 cycles (8 weeks) from start of treatment until documented disease progression or death from any cause. RR - Baseline to disease progression PK – Cycle 1 ( Day,1,3,14,15,16) Safety – Every Cycle until study discontinuation Patient-reported symptoms and neurocognitive function - Every 2 cycles (8 weeks) from baseline until study discontinuation Prognostic and predictive marker assessment Cycle 1 | — |
Countries
Australia, Belgium, Canada, Germany, Italy, Netherlands, Poland, Spain, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly and Company
Outcome results
None listed