A Study in Recurrent Glioblastoma

Phase 1

Conditions: Glioblastoma
MedDRA version: 18.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-004418-40-DE

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Overall Survival ;Secondary Objective: PK of LY2157299 monohydrate. <br>Evaluate Safety <br>Prognostic and predictive marker assessment<br>Progression-free survival , median OS and PFS, OS and PFS rates at 6 months<br>Tumor response rate <br>Assess patient-reported symptoms and neurocognitive function <br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Progression-free survival and PFS rate at 6 months, 9 months, 12 months <br>Median OS and at 6 months<br>Tumor response rate<br>PK of LY2157299 monohydrate. <br>Evaluate Safety (safety parameters are reduced in the continued access<br>period)<br>Prognostic and predictive marker assessment<br>Tumor response rate RANO criteria <br>Change in patient-reported symptoms and neurocognitive function <br>;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.<br>RR - Baseline to disease progression<br>PK – Cycle 1 ( Day,1,3,14,15,16)<br>Safety – Every Cycle until study discontinuation<br>Patient-reported symptoms and neurocognitive function - Every 2 cycles (8 weeks) from baseline until study discontinuation<br>Prognostic and predictive marker assessment Cycle 1<br>