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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/NCT02573324




Registration number
NCT02573324
Ethics application status
Date submitted
28/09/2015
Date registered
9/10/2015
Date last updated
11/05/2023

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: Other - Radiation
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: Other: Radiation


Treatment: Drugs: Placebo for ABT-414
IV Infusion (IV)
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
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
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Duplicate_The Prince of Wales Hospital /ID# 144882 - Randwick
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Royal North Shore Hospital /ID# 143870 - St Leonards
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Calvary Mater Newcastle /ID# 143860 - Waratah
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Southern Medical Day Care Centre /ID# 143868 - Wollongong
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Princess Alexandra Hospital /ID# 143857 - Woolloongabba
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Royal Adelaide Hospital /ID# 143867 - Adelaide
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Calvary North Adelaide Hospita /ID# 143866 - Adelaide
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St Vincent's Hospital Melbourne /ID# 143858 - Fitzroy Melbourne
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Duplicate_Austin Hospital /ID# 143859 - Heidelberg
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St John Of God Subiaco Hospital /ID# 143869 - Subiaco
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2170 - Liverpool
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2031 - Randwick
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2065 - St Leonards
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2298 - Waratah
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2500 - Wollongong
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4102 - Woolloongabba
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5000 - Adelaide
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5006 - Adelaide
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3065 - Fitzroy Melbourne
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3084 - Heidelberg
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6008 - Subiaco
Recruitment outside Australia
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Bern
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London, City Of
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Newcastle Upon Tyne
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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
This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and
temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall
survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal
growth factor receptor (EGFR) amplification.

In addition, there is a Phase 1, open-label, multicenter sub-study to assess the
pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed
EGFR-amplified GBM who have mild or moderate hepatic impairment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02573324
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02573324