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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02573324




Registration number
NCT02573324
Ethics application status
Date submitted
28/09/2015
Date registered
9/10/2015

Titles & IDs
Public title
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Scientific title
A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
Secondary ID [1] 0 0
2015-001166-26
Secondary ID [2] 0 0
M13-813
Universal Trial Number (UTN)
Trial acronym
Intellance1
Linked study record

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

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Temozolomide
Treatment: Drugs - Depatuxizumab mafodotin
Treatment: Drugs - Placebo for ABT-414

Experimental: Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ) - Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.

Placebo comparator: Placebo, Radiation and TMZ - Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.

Experimental: Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ - Depatuxizumab mafodotin is given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.


Treatment: Drugs: Temozolomide
Oral Capsule

Treatment: Drugs: Depatuxizumab mafodotin
Intravenous (IV) Infusion

Treatment: Drugs: Placebo for ABT-414
IV Infusion (IV)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary outcome [1] 0 0
OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group
Timepoint [1] 0 0
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary outcome [2] 0 0
OS for the MGMT Methylated Group
Timepoint [2] 0 0
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary outcome [3] 0 0
OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup
Timepoint [3] 0 0
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary outcome [4] 0 0
Progression-Free Survival (PFS)
Timepoint [4] 0 0
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary outcome [5] 0 0
PFS for EGFRvIII-Mutated Tumor Subgroup
Timepoint [5] 0 0
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary outcome [6] 0 0
Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score
Timepoint [6] 0 0
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary outcome [7] 0 0
Deterioration Free Survival in MDASI-BT Symptom Interference Score
Timepoint [7] 0 0
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary outcome [8] 0 0
Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score
Timepoint [8] 0 0
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Eligibility
Key inclusion criteria
* Must have a clinical diagnosis of glioblastoma (GBM).
* Must have a confirmed epidermal growth factor receptor amplification in tumor tissue.
* Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study).
* Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
* Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment).
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM).
* Prior chemo therapy or radiosensitizer for head and neck cancer.
* Prior radiotherapy to the head or neck in overlap of radiation fields.
* Prior therapy for glioblastoma or other invasive malignancy.
* Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

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 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
4/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/04/2022
Sample size
Target
Accrual to date
Final
691
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital /ID# 144392 - Liverpool
Recruitment hospital [2] 0 0
Duplicate_The Prince of Wales Hospital /ID# 144882 - Randwick
Recruitment hospital [3] 0 0
Royal North Shore Hospital /ID# 143870 - St Leonards
Recruitment hospital [4] 0 0
Calvary Mater Newcastle /ID# 143860 - Waratah
Recruitment hospital [5] 0 0
Southern Medical Day Care Centre /ID# 143868 - Wollongong
Recruitment hospital [6] 0 0
Princess Alexandra Hospital /ID# 143857 - Woolloongabba
Recruitment hospital [7] 0 0
Royal Adelaide Hospital /ID# 143867 - Adelaide
Recruitment hospital [8] 0 0
Calvary North Adelaide Hospita /ID# 143866 - Adelaide
Recruitment hospital [9] 0 0
St Vincent's Hospital Melbourne /ID# 143858 - Fitzroy Melbourne
Recruitment hospital [10] 0 0
Duplicate_Austin Hospital /ID# 143859 - Heidelberg
Recruitment hospital [11] 0 0
St John Of God Subiaco Hospital /ID# 143869 - Subiaco
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5006 - Adelaide
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy Melbourne
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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Arkansas
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Delaware
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Illinois
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Indiana
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Kansas
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Maine
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Massachusetts
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Michigan
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Wisconsin
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Argentina
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Santa Fe
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Buenos Aires
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Austria
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Steiermark
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Austria
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Wien
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Austria
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Linz
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Brno
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Germany
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Israel
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Piemonte
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Milan
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Padova
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Rome
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Gyeonggido
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Seoul Teugbyeolsi
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Korea, Republic of
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Seoul
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Mexico
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Nuevo Leon
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Netherlands
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Amsterdam
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Den Haag
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Groningen
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Maastricht
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Utrecht
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Christchurch
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New Zealand
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Wellington
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Portugal
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Braga
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Faro
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Lisboa
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Portugal
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Porto
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Russian Federation
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Kaliningradskaya Oblast
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Russian Federation
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Kirovskaya Oblast
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Russian Federation
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Moskovskaya Oblast
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Russian Federation
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Moskva
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Russian Federation
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Sverdlovskaya Oblast
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Singapore
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Singapore
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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Kwazulu-Natal
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South Africa
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Western Cape
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Spain
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Malaga
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Switzerland
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Aargau
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Switzerland
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Zuerich
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Switzerland
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Bellinzona
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Switzerland
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Bern
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Taiwan
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Taipei City
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Taiwan
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Taoyuan City
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United Kingdom
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London, City Of
Country [129] 0 0
United Kingdom
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Birmingham
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United Kingdom
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Cardiff
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United Kingdom
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Dundee
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United Kingdom
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Edinburgh
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Radiation Therapy Oncology Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
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?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02573324