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Alkylating agent
LY2157299 + Lomustine for Brain Cancer
Phase 2
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Progressive Disease (PD) following standard chemoradiation
Tumor specimen must be available for a central pathology review and prognostic and predictive biomarker evaluation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 cycles to disease progression or participant starts a new anticancer therapy estimated up to 2 years
Awards & highlights
Study Summary
This trial is testing LY2157299, a cancer drug, to see if it can help people with brain cancer.
Who is the study for?
This trial is for adults with a confirmed diagnosis of recurrent glioblastoma, who have seen their cancer progress after standard treatment. They must have good performance status (able to carry out daily activities), and adequate organ function. Participants should not have other cancers or serious diseases that could interfere with the study, nor prior treatments that might affect results.Check my eligibility
What is being tested?
The study tests if LY2157299 alone, or combined with lomustine (a chemotherapy drug), is more effective than lomustine paired with a placebo in treating brain cancer. The goal is to determine which treatment helps patients better.See study design
What are the potential side effects?
LY2157299 and lomustine can cause side effects like fatigue, nausea, blood cell count changes leading to increased infection risk or bleeding problems, liver and kidney function alterations, and potential heart issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened after receiving standard chemoradiation.
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My tumor sample is available for further testing.
Select...
My brain tumor has returned after treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 2 cycles to disease progression or participant starts a new anticancer therapy estimated up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 cycles to disease progression or participant starts a new anticancer therapy estimated up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Change from baseline in MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) score
Change from baseline in neurocognitive function
Percentage of Participants with Tumor Response
+4 moreSide effects data
From 2016 Phase 2 trial • 83 Patients • NCT0106746939%
ALT/SGPT
17%
anorexia
14%
AST/SGOT
11%
alk phos
6%
Fracture
6%
allergic rhinitis
6%
CNS Ischemia
6%
Confusion
3%
Headache
3%
Perforation, GI
3%
Vessel injury - artery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Dose Bevacizumab
Low Dose Bevacizumab + Lomustine
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: LY2157299 monohydrate plus lomustineExperimental Treatment2 Interventions
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.
Group II: LY2157299 monohydrateExperimental Treatment1 Intervention
300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle (unblinded)
Group III: lomustine plus placeboActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lomustine
FDA approved
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,749 Total Patients Enrolled
8 Trials studying Glioblastoma
1,035 Patients Enrolled for Glioblastoma
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,072 Total Patients Enrolled
3 Trials studying Glioblastoma
213 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has worsened after receiving standard chemoradiation.I have had surgery to remove a tumor.My blood, liver, and kidney functions are all within normal ranges.I have stopped all previous cancer treatments and recovered from their immediate side effects.My tumor sample is available for further testing.I have been diagnosed with acute or chronic myelogenous leukemia.My brain tumor has returned after treatment.I have another type of cancer that could interfere with the study results.You have a serious ongoing health condition that affects your whole body.I have moderate or severe heart disease.I am fully active or restricted in physically strenuous activity but can do light work.I had bevacizumab for brain cancer but finished it over a year ago.I have previously received nitrosurea-based therapy.
Research Study Groups:
This trial has the following groups:- Group 1: LY2157299 monohydrate
- Group 2: LY2157299 monohydrate plus lomustine
- Group 3: lomustine plus placebo
Awards:
This trial has 1 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent are hospitals administering this experiment?
"At this time, the trial is bringing on individuals from 7 clinical sites; these are located in Dallas, Montreal and San Francisco among other cities. In order to reduce transportation needs for participants, it's recommended that you join a clinic close to your residence."
Answered by AI
Are there any remaining spots available for this study?
"At the present time, enrollment in this trial has been closed. The initial posting was on April 26th 2012 and the most recent edits were made October 18th 2022. If you are looking for alternative trials to apply to, there are 441 studies recruiting participants with glioblastoma and 25 clinical investigations utilizing Lomustine currently seeking enrollees."
Answered by AI
What risks are associated with the use of Lomustine?
"The safety of lomustine is estimated to be a score of 2 as there are some clinical data backing its security, yet no information exists on the efficacy of this drug."
Answered by AI
What is the participant recruitment total for this trial?
"Presently, this medical trial is not recruiting any further patients. It was officially posted on the 26th of April 2012 and the most recent update occurred 18th October 2022. If you are looking for alternative studies, there are 441 trials available regarding glioblastoma and 25 clinical trials involving lomustine with active recruitment taking place."
Answered by AI
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