UNITE Study: Understanding New Interventions With GBM ThErapy
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
Have a question?
You can ask us questions via online form or phone call.
Call us @: 844 663-3742
| Location | Status | Site Contact Details |
|---|---|---|
Location Usc, Los Angeles, California, 90033 | Status Not Available | |
Location Moffitt Cancer Center, Tampa, Florida, 33612-9416 | Status Not Available | |
Location Rush University Medical Center, Chicago, Illinois, 60612 | Status Not Available | |
Location Northshore University Health System-Evanston, Evanston, Illinois, 60201 | Status Not Available | |
Location CDH-Delnor Health System, Warrenville, Illinois, 60555 | Status Not Available | |
Location Columbia University Medical Center, New York, New York, 10032-3729 | Status Not Available | |
Location Levine Cancer Ins, Carolina Me, Charlotte, North Carolina, 28204 | Status Not Available | |
Location UT Health Science Ctr-Houston, Houston, Texas, 77030 | Status Not Available | |
Location Baylor Scott & White Medical Center- Temple, Temple, Texas, 76508-0001 | Status Not Available |
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).
Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management
Time Frame: Within 8 weeks after the initial dose of depatuxizumab mafodotin
Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale
Time Frame: Within 8 weeks after the initial dose of depatuxizumab mafodotin
Time to Bandage Contact Lens (BCL) Intervention
Time Frame: Up to 9 months after the first dose of depatuxizumab mafodotin
Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE)
Time Frame: From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment
Time Frame: Up to 9 months
Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit
Time Frame: Up to 47 weeks
Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention
Time Frame: From the last assessment prior to BCL intervention to 2 weeks after BCL intervention
Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention
Time Frame: From the last assessment prior to BCL intervention to the end of BCL intervention
Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Time Frame: From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Time Frame: From the last assessment prior to BCL intervention to the end of BCL intervention
Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention
Time Frame: From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility)
Time Frame: From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption
Time Frame: Up to 9 months
Interventions:
- Drug: Steroid eye drops
- Drug: Steroid eye drops
- Drug: Steroid eye drops
- Drug: Vasoconstrictor eye drops
- Drug: Vasoconstrictor eye drops
- Other: Cold compress
- Other: Cold compress
- Drug: Ophthalmic steroid ointment
- Drug: Depatuxizumab mafodotin
- Drug: Depatuxizumab mafodotin
- Drug: Depatuxizumab mafodotin
- Drug: Temozolomide
- Drug: Temozolomide
- Drug: Temozolomide
- Radiation: Radiation
- Radiation: Radiation
- Radiation: Radiation
Enrollment:
40
Available Documents
FaFilePdfUnmappedFaFilePdfUnmappedFaFilePdfPlain Language Summary (English)FaFilePdfPlain Language Summary (German)Additional Information
Watch a video to learn more about what you may experience as a clinical trial volunteer: /resources/what-happens-in-a-clinical-trial
Take a virtual reality screening visit tour to an example of a clinical trial site: /resources/screening-visit-virtual-tour
Use a questionnaire tool to think through questions to ask yourself about participating in a clinical trial and print out your responses to discuss with your partners in your health journey: /resource-information-clinical-trial-community/decision-counselor