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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00295815




Registration number
NCT00295815
Ethics application status
Date submitted
22/02/2006
Date registered
24/02/2006

Titles & IDs
Public title
Enzastaurin Versus Lomustine in Glioblastoma
Scientific title
Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma
Secondary ID [1] 0 0
H6Q-MC-JCBF
Secondary ID [2] 0 0
9817
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 - enzastaurin
Treatment: Drugs - lomustine

Experimental: A -

Active comparator: B -


Treatment: Drugs: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD

Treatment: Drugs: lomustine
100-130 mg/m2, oral once, every 6 weeks until PD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective is to compare Enzastaurin versus Lomustine in patients who for the second time have brain cancer (specifically intracranial glioblastoma) to see what effect the drugs have on keeping the disease from progressing (worsening).
Timepoint [1] 0 0
baseline to measured progressive disease (PD)
Secondary outcome [1] 0 0
To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique).
Timepoint [1] 0 0
time of response to progressive disease
Secondary outcome [2] 0 0
To measure changes in patient's ability to care for themselves (this will be determined through a standard survey).
Timepoint [2] 0 0
over entire study
Secondary outcome [3] 0 0
To measure changes from baseline and a neurologic exam.
Timepoint [3] 0 0
baseline, each cycle
Secondary outcome [4] 0 0
To review all bad reactions reported by the patient and detected in blood tests.
Timepoint [4] 0 0
each cycle
Secondary outcome [5] 0 0
To review the effect of the cancer on the patient's ability to care for themselves and on their general health status.
Timepoint [5] 0 0
over entire study
Secondary outcome [6] 0 0
To determine through blood tests how long the medication is in the patient's body.
Timepoint [6] 0 0
cycle 1, cycle 4
Secondary outcome [7] 0 0
To review through testing of tumor and blood samples to see if there are reasons why some patients responded to the drugs better than other patients.
Timepoint [7] 0 0
baseline, cycle 2, end of study

Eligibility
Key inclusion criteria
1. Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme).
2. Your cancer has returned following therapy.
3. Patient may have undergone prior surgery to remove cancer.
4. Patient must be able to care for self.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a second type of cancer (except adequately treated basal cell carcinoma of the skin). Patient who has had another cancer in the past, must be free of cancer for more than 2 years.
2. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of entry.
3. Patients receiving medication for seizures must discontinue 14 days prior to enrolling.
4. Cannot be on blood thinning medication at study enrollment.
5. Cannot be on other medicines to prevent cancer at study enrollment.
6. Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
397
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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. - Liverpool
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. - St Leonards
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. - Auchenflower
Recruitment hospital [4] 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 [5] 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. - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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Arizona
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Graz
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Tlalpan
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Toluca
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Amsterdam
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Lublin
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Warsaw
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Badalona
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Hospitalet Llobregat
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Madrid
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Oviedo
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Valencia
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United Kingdom
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Avon
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Cambridgeshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM 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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Wick W, Puduvalli VK, Chamberlain MC, van den Bent... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT00295815