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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01582269




Registration number
NCT01582269
Ethics application status
Date submitted
19/04/2012
Date registered
20/04/2012
Date last updated
23/10/2024

Titles & IDs
Public title
A Study in Recurrent Glioblastoma (GB)
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
Secondary ID [1] 0 0
H9H-MC-JBAL
Secondary ID [2] 0 0
13849
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Date of randomization to date of death from any cause estimated up to 2 years
Secondary outcome [1] 0 0
Population Pharmacokinetics (PK): median population clearance
Timepoint [1] 0 0
Cycle 1, Day 1, 3, 14, 15 and 16
Secondary outcome [2] 0 0
Progression free survival (PFS)
Timepoint [2] 0 0
Randomization to the date of objective progression or death from any cause estimated up to 2 years
Secondary outcome [3] 0 0
Percentage of Participants with Tumor Response
Timepoint [3] 0 0
Every 2 cycles to disease progression or participant starts a new anticancer therapy estimated up to 2 years
Secondary outcome [4] 0 0
Change from baseline in neurocognitive function
Timepoint [4] 0 0
Baseline, cycle 1, cycle 2 then every 2 cycles to 30 day post discontinuation follow up estimated up to 2 years
Secondary outcome [5] 0 0
Population Pharmacokinetics (PK): absorption
Timepoint [5] 0 0
Cycle 1, Day 1, 3, 14, 15 and 16
Secondary outcome [6] 0 0
Population Pharmacokinetics (PK): volume of distribution
Timepoint [6] 0 0
Cycle 1, Day 1, 3, 14, 15 and 16
Secondary outcome [7] 0 0
Change from baseline in MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) score
Timepoint [7] 0 0
Baseline, cycle 1, cycle 2 then every 2 cycles to 30 day post discontinuation follow up estimated up to 2 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/10/2024
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment hospital [3] 0 0
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
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Belgium
State/province [5] 0 0
Edegem
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Liège
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
France
State/province [10] 0 0
Bobigny
Country [11] 0 0
France
State/province [11] 0 0
Lyon
Country [12] 0 0
France
State/province [12] 0 0
Marseille
Country [13] 0 0
France
State/province [13] 0 0
Nancy
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
Germany
State/province [15] 0 0
Bonn
Country [16] 0 0
Germany
State/province [16] 0 0
Frankfurt
Country [17] 0 0
Germany
State/province [17] 0 0
Hamburg
Country [18] 0 0
Germany
State/province [18] 0 0
Heidelberg
Country [19] 0 0
Italy
State/province [19] 0 0
Bologna
Country [20] 0 0
Italy
State/province [20] 0 0
Terni
Country [21] 0 0
Italy
State/province [21] 0 0
Udine
Country [22] 0 0
Poland
State/province [22] 0 0
Lodz
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT01582269
Trial related presentations / publications
Smith CL, Thomas Z, Enas N, Thorn K, Lahn M, Benhadji K, Cleverly A. Leveraging historical data into oncology development programs: Two case studies of phase 2 Bayesian augmented control trial designs. Pharm Stat. 2020 May;19(3):276-290. doi: 10.1002/pst.1990. Epub 2020 Jan 5.
Brandes AA, Carpentier AF, Kesari S, Sepulveda-Sanchez JM, Wheeler HR, Chinot O, Cher L, Steinbach JP, Capper D, Specenier P, Rodon J, Cleverly A, Smith C, Gueorguieva I, Miles C, Guba SC, Desaiah D, Lahn MM, Wick W. A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma. Neuro Oncol. 2016 Aug;18(8):1146-56. doi: 10.1093/neuonc/now009. Epub 2016 Feb 21.
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01582269