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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/NCT03419403
Registration number
NCT03419403
Ethics application status
Date submitted
26/01/2018
Date registered
5/02/2018
Date last updated
14/04/2021
Titles & IDs
Public title
UNITE Study: Understanding New Interventions With GBM ThErapy
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Scientific title
Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
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Secondary ID [1]
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2017-003171-64
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Secondary ID [2]
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M16-534
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glioblastoma Multiforme
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Condition category
Condition code
Cancer
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Brain
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Intervention/exposure
Study type
Interventional(has expanded access)
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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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Intervention code [3]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management
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Assessment method [1]
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Inadequate control of ocular side effects (OSE) was defined as either a = 3-line decline from baseline (= +0.3 on LogMAR scale) in visual acuity (with baseline correction determined at the screening ophthalmology visit)) or = Grade 3 OSE severity on the Corneal Epithelial Adverse Event (CEAE) scale.
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Timepoint [1]
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Within 8 weeks after the initial dose of depatuxizumab mafodotin
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Secondary outcome [1]
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Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale
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Assessment method [1]
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The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. The baseline observation is defined as the last non-missing measurement collected prior to the first dose of depatuxizumab mafodotin.
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Timepoint [1]
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Within 8 weeks after the initial dose of depatuxizumab mafodotin
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Secondary outcome [2]
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Time to Bandage Contact Lens (BCL) Intervention
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Assessment method [2]
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The time to initiation of bandage contact lenses for those participants who required intervention due to inadequate control of ocular side effects (OSE) was calculated.
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Timepoint [2]
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Up to 9 months after the first dose of depatuxizumab mafodotin
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Secondary outcome [3]
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Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE)
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Assessment method [3]
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Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs.
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Timepoint [3]
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From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
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Secondary outcome [4]
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Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment
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Assessment method [4]
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The cumulative dose of depatuxizumab mafodotin administered was tabulated.
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Timepoint [4]
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Up to 9 months
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Secondary outcome [5]
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Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit
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Assessment method [5]
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The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).
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Timepoint [5]
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Up to 47 weeks
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Secondary outcome [6]
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Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention
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Assessment method [6]
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The change on the LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention was calculated. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
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Timepoint [6]
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From the last assessment prior to BCL intervention to 2 weeks after BCL intervention
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Secondary outcome [7]
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Percentage of Participants That Recovered to <3-line Decline From Baseline (= +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention
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Assessment method [7]
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Recovery was defined as return to <3-line decline from baseline (= +0.3 LogMAR) in visual acuity after BCL intervention.
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Timepoint [7]
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From the last assessment prior to BCL intervention to the end of BCL intervention
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Secondary outcome [8]
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Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
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Assessment method [8]
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Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs after BCL intervention.
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Timepoint [8]
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From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
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Secondary outcome [9]
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Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
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Assessment method [9]
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The time to restart depatuxizumab mafodotin treatment if it was interrupted due to ocular side effects after BCL Intervention was tabulated.
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Timepoint [9]
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From the last assessment prior to BCL intervention to the end of BCL intervention
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Secondary outcome [10]
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Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention
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Assessment method [10]
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The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).
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Timepoint [10]
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From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
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Secondary outcome [11]
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Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility)
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Assessment method [11]
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The time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility) was to be recorded.
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Timepoint [11]
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From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
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Secondary outcome [12]
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Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption
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Assessment method [12]
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The time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin was to be recorded.
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Timepoint [12]
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Up to 9 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/03/2020
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal North Shore Hospital /ID# 169673 - Saint Leonards
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Recruitment hospital [2]
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Calvary Mater Newcastle /ID# 169672 - Waratah
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Recruitment hospital [3]
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Royal Brisbane and Women's Hospital /ID# 169674 - Herston
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Recruitment hospital [4]
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Austin Hospital /ID# 169671 - Heidelberg
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Recruitment postcode(s) [1]
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2065 - Saint Leonards
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Recruitment postcode(s) [2]
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2298 - Waratah
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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New York
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Country [5]
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United States of America
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North Carolina
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Country [6]
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United States of America
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Texas
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Country [7]
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Germany
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State/province [7]
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Baden-Wuerttemberg
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Country [8]
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Germany
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Sachsen
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Germany
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Regensburg
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Germany
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State/province [10]
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Tuebingen
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Netherlands
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State/province [11]
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Amsterdam
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Netherlands
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State/province [12]
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Utrecht
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Country [13]
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United Kingdom
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State/province [13]
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London, City Of
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Country [14]
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United Kingdom
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Birmingham
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United Kingdom
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State/province [15]
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Cottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this study was to evaluate the effect of several ophthalmologic prophylactic
treatment strategies for the management of ocular side effects (OSEs) in participants with
epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated
with depatuxizumab mafodotin (ABT-414).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03419403
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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AbbVie Inc.
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Address
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AbbVie
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03419403
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