A Study in Recurrent Glioblastoma (GB)

Phase 2

Completed

• Conditions: Glioblastoma
• Interventions: Drug: LY2157299 monohydrate; Drug: Placebo; Drug: Lomustine

• Registration Number: NCT01582269
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299 plus lomustine therapy or lomustine plus placebo can help participants with brain cancer

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Study Start: 2012-04-26
• Primary Completion: 2014-07-26
• Disposition First Submitted: 2014-09-29
• Disposition First Submitted QC: 2014-09-29
• Disposition First Posted: 2014-10-08
• Status Verified: 2024-10
• Study Completion: 2024-10-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Histological confirmed diagnosis of relapsed intracranial GB
• Progressive Disease (PD) following standard chemoradiation
• Prior surgical resection allowed
• Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Adequate hematologic, hepatic and renal function
• Discontinued all prior cancer treatments for cancer & recovered from the acute effects of therapy
• Tumor specimen must be available for a central pathology review and prognostic and predictive biomarker evaluation

Exclusion Criteria

• Moderate or severe heart disease based on New York Heart Association (NYHA) criteria
• Prior nitrosurea therapy (including lomustine or Gliadel)
• Prior bevacizumab as 1st line treatment for GB (if treatment was concluded 12 months prior to enrollment, the patient may be eligible to participate in the trial)
• Current acute or chronic myelogenous leukemia
• Second primary malignancy that may affect the interpretation of results
• Serious concomitant systemic disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY2157299 monohydrate plus lomustine	LY2157299 monohydrate	300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle. First lomustine dose will be given as 100 mg/m2 on day 7 cycle 1. Remaining doses are based on the investigator's discretion and will be given orally once every 6 weeks in capsules to equal 100 to 130 mg/m2.
LY2157299 monohydrate	LY2157299 monohydrate	300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle (unblinded)
lomustine plus placebo	Placebo	First lomustine dose will be given as 100 mg/m2 on day 7 cycle 1. Remaining doses are based on the investigator's discretion and will be given orally once every 6 weeks in capsules to equal 100 to 130 mg/m2. LY2157299 monohydrate-matched placebo, given orally as tablets for 14 days, followed by 14 days of rest, equaling a 28-day cycle.
LY2157299 monohydrate plus lomustine	Lomustine	300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle. First lomustine dose will be given as 100 mg/m2 on day 7 cycle 1. Remaining doses are based on the investigator's discretion and will be given orally once every 6 weeks in capsules to equal 100 to 130 mg/m2.
lomustine plus placebo	Lomustine	First lomustine dose will be given as 100 mg/m2 on day 7 cycle 1. Remaining doses are based on the investigator's discretion and will be given orally once every 6 weeks in capsules to equal 100 to 130 mg/m2. LY2157299 monohydrate-matched placebo, given orally as tablets for 14 days, followed by 14 days of rest, equaling a 28-day cycle.

Primary Outcome Measures

Name	Time	Method
Overall survival	Date of randomization to date of death from any cause estimated up to 2 years

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Tumor Response	Every 2 cycles to disease progression or participant starts a new anticancer therapy estimated up to 2 years
Population Pharmacokinetics (PK): median population clearance	Cycle 1, Day 1, 3, 14, 15 and 16
Progression free survival (PFS)	Randomization to the date of objective progression or death from any cause estimated up to 2 years
Change from baseline in neurocognitive function	Baseline, cycle 1, cycle 2 then every 2 cycles to 30 day post discontinuation follow up estimated up to 2 years
Population Pharmacokinetics (PK): absorption	Cycle 1, Day 1, 3, 14, 15 and 16
Population Pharmacokinetics (PK): volume of distribution	Cycle 1, Day 1, 3, 14, 15 and 16
Change from baseline in MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) score	Baseline, cycle 1, cycle 2 then every 2 cycles to 30 day post discontinuation follow up estimated up to 2 years

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇪🇸 Barcelona, Spain