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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03419403




Registration number
NCT03419403
Ethics application status
Date submitted
26/01/2018
Date registered
5/02/2018

Titles & IDs
Public title
UNITE Study: Understanding New Interventions With GBM ThErapy
Scientific title
Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
Secondary ID [1] 0 0
2017-003171-64
Secondary ID [2] 0 0
M16-534
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma Multiforme 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 - Steroid eye drops
Treatment: Drugs - Vasoconstrictor eye drops
Other interventions - Cold compress
Treatment: Drugs - Ophthalmic steroid ointment
Treatment: Drugs - Depatuxizumab mafodotin
Treatment: Drugs - Temozolomide
Treatment: Other - Radiation

Experimental: Standard Steroids - Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days

Experimental: Standard Steroids + Vasoconstrictor + Cold Compress - Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable).

Experimental: Enhanced Steroids + Vasoconstrictor + Cold Compress - Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable).


Treatment: Drugs: Steroid eye drops
Solution, eye drop

Treatment: Drugs: Vasoconstrictor eye drops
Solution, eye drop

Other interventions: Cold compress
Cold compress

Treatment: Drugs: Ophthalmic steroid ointment
Ointment

Treatment: Drugs: Depatuxizumab mafodotin
During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles.

Treatment: Drugs: Temozolomide
Temozolomide was to be administered according to the local standard of care. Duration of treatment was to be 6 - 12 cycles in the adjuvant phase and at the discretion of the investigator as supported by local standard of care.

Treatment: Other: Radiation
Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management
Timepoint [1] 0 0
Within 8 weeks after the initial dose of depatuxizumab mafodotin
Secondary outcome [1] 0 0
Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale
Timepoint [1] 0 0
Within 8 weeks after the initial dose of depatuxizumab mafodotin
Secondary outcome [2] 0 0
Time to Bandage Contact Lens (BCL) Intervention
Timepoint [2] 0 0
Up to 9 months after the first dose of depatuxizumab mafodotin
Secondary outcome [3] 0 0
Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE)
Timepoint [3] 0 0
From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Secondary outcome [4] 0 0
Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment
Timepoint [4] 0 0
Up to 9 months
Secondary outcome [5] 0 0
Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit
Timepoint [5] 0 0
Up to 47 weeks
Secondary outcome [6] 0 0
Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention
Timepoint [6] 0 0
From the last assessment prior to BCL intervention to 2 weeks after BCL intervention
Secondary outcome [7] 0 0
Percentage of Participants That Recovered to <3-line Decline From Baseline (= +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention
Timepoint [7] 0 0
From the last assessment prior to BCL intervention to the end of BCL intervention
Secondary outcome [8] 0 0
Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Timepoint [8] 0 0
From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Secondary outcome [9] 0 0
Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Timepoint [9] 0 0
From the last assessment prior to BCL intervention to the end of BCL intervention
Secondary outcome [10] 0 0
Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention
Timepoint [10] 0 0
From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Secondary outcome [11] 0 0
Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility)
Timepoint [11] 0 0
From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Secondary outcome [12] 0 0
Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption
Timepoint [12] 0 0
Up to 9 months

Eligibility
Key inclusion criteria
* Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma
* Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification
* Tumors must be supratentorial in location
* Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage
* Participant has a Karnofsky performance status (KPS) of 70 or higher
* Participant has adequate bone marrow, renal, and hepatic function
* Electrocardiogram without evidence of acute cardiac ischemia = 21 days prior to randomization
* Participant has a life expectancy of = 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant has received prior chemotherapy or radiotherapy for cancer of the head and neck region
* Participant has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment
* Participant has hypersensitivity to any component of temozolomide or dacarbazine
* Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1
* Participant has clinically significant uncontrolled condition(s) as described in the protocol
* Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities
* Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin
* Participant has a history of herpetic keratitis
* Participant is not suitable for receiving ocular steroids with conditions as described in the protocol
* Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months
* Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs)
* Participant has hepatitis B virus or hepatitis C virus infection
* Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV)

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/03/2020
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital /ID# 169673 - Saint Leonards
Recruitment hospital [2] 0 0
Calvary Mater Newcastle /ID# 169672 - Waratah
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital /ID# 169674 - Herston
Recruitment hospital [4] 0 0
Austin Hospital /ID# 169671 - Heidelberg
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Germany
State/province [7] 0 0
Baden-Wuerttemberg
Country [8] 0 0
Germany
State/province [8] 0 0
Sachsen
Country [9] 0 0
Germany
State/province [9] 0 0
Regensburg
Country [10] 0 0
Germany
State/province [10] 0 0
Tuebingen
Country [11] 0 0
Netherlands
State/province [11] 0 0
Amsterdam
Country [12] 0 0
Netherlands
State/province [12] 0 0
Utrecht
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London, City Of
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Birmingham
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Cottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

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 and 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)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


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/NCT03419403