Glioblastoma MedDRA version: 14.1 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: N/A
CAS Number: N/A
Current Sponsor code: LY2157299 Monohydrate
Other descripti
Sponsors
Lilly S.A,
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 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
Lilly S.A.
Outcome results
None listed