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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01582269
Registration number
NCT01582269
Ethics application status
Date submitted
19/04/2012
Date registered
20/04/2012
Date last updated
6/06/2024
Titles & IDs
Public title
A Study in Recurrent Glioblastoma (GB)
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Scientific title
A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma
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Secondary ID [1]
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H9H-MC-JBAL
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Secondary ID [2]
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13849
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glioblastoma
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Condition category
Condition code
Cancer
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LY2157299 monohydrate
Treatment: Drugs - Lomustine
Treatment: Drugs - Placebo
Experimental: LY2157299 monohydrate plus 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.
Experimental: LY2157299 monohydrate - 300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle (unblinded)
Active Comparator: lomustine plus 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.
Treatment: Drugs: LY2157299 monohydrate
Orally administered as tablets
Treatment: Drugs: Lomustine
Orally administered as capsules
Treatment: Drugs: Placebo
Orally administered as tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival
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Assessment method [1]
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Timepoint [1]
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Date of randomization to date of death from any cause estimated up to 2 years
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Secondary outcome [1]
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Population Pharmacokinetics (PK): median population clearance
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Assessment method [1]
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Timepoint [1]
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Cycle 1, Day 1, 3, 14, 15 and 16
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Secondary outcome [2]
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Progression free survival (PFS)
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Assessment method [2]
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Timepoint [2]
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Randomization to the date of objective progression or death from any cause estimated up to 2 years
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Secondary outcome [3]
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Percentage of Participants with Tumor Response
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Assessment method [3]
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Timepoint [3]
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Every 2 cycles to disease progression or participant starts a new anticancer therapy estimated up to 2 years
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Secondary outcome [4]
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Change from baseline in neurocognitive function
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Assessment method [4]
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Timepoint [4]
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Baseline, cycle 1, cycle 2 then every 2 cycles to 30 day post discontinuation follow up estimated up to 2 years
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Secondary outcome [5]
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Population Pharmacokinetics (PK): absorption
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Assessment method [5]
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Timepoint [5]
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Cycle 1, Day 1, 3, 14, 15 and 16
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Secondary outcome [6]
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Population Pharmacokinetics (PK): volume of distribution
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Assessment method [6]
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Timepoint [6]
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Cycle 1, Day 1, 3, 14, 15 and 16
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Secondary outcome [7]
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Change from baseline in MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) score
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Assessment method [7]
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Timepoint [7]
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Baseline, cycle 1, cycle 2 then every 2 cycles to 30 day post discontinuation follow up estimated up to 2 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/04/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2024
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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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. - St. Leonards
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Recruitment hospital [2]
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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. - Heidelberg
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Recruitment hospital [3]
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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. - Parkville
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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United States of America
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State/province [3]
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Ohio
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Belgium
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State/province [5]
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Edegem
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Country [6]
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Belgium
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State/province [6]
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Gent
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Country [7]
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Belgium
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State/province [7]
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Liège
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
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Canada
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State/province [9]
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Quebec
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Country [10]
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France
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State/province [10]
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Bobigny
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Country [11]
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France
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State/province [11]
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Lyon
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Country [12]
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France
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State/province [12]
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Marseille
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Country [13]
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France
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State/province [13]
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Nancy
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Country [14]
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France
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State/province [14]
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Paris
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Country [15]
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Germany
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State/province [15]
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Bonn
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Country [16]
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Germany
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State/province [16]
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Frankfurt
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Country [17]
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Germany
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State/province [17]
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Hamburg
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Germany
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State/province [18]
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Heidelberg
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Country [19]
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Italy
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State/province [19]
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Bologna
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Country [20]
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Italy
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State/province [20]
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Terni
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Country [21]
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Italy
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State/province [21]
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Udine
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Poland
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State/province [22]
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Lodz
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Country [23]
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Spain
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State/province [23]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01582269
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01582269
Download to PDF