Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03419403) enrolled 40 people in total across four groups. Three groups received the cancer drug depatuxizumab mafodotin alongside different combinations of eye-protection strategies: "Standard Steroids" (14 people), "Standard Steroids plus a vasoconstrictor eye drop and cold compress" (12 people), and "Enhanced Steroids plus a vasoconstrictor eye drop and cold compress" (12 people). A small fourth group of 2 people received no eye-protection treatment. The trial was measuring whether different approaches to managing eye side effects — such as drops, compresses, and steroid medicines — could prevent those side effects from becoming serious enough to require a change in how they were managed. It is worth noting that very few participants completed the study: only 2, 3, and 0 in the first three groups respectively, with none completing in the fourth group. The reported data shows that for the primary outcome — the percentage of participants whose eye side effects became poorly controlled and needed a change in management — the figures were 50% in the Standard Steroids group, 27.3% in the Standard Steroids plus vasoconstrictor and cold compress group, and 41.7% in the Enhanced Steroids plus vasoconstrictor and cold compress group. For a secondary measure of vision change (using a scale called LogMAR, where higher numbers mean greater change from normal vision), the reported average maximum changes from each person's starting point were 0.353, 0.402, and 0.272 across the three groups respectively. Regarding dose changes to the cancer drug caused by eye side effects, 2, 3, and 2 participants in each group respectively had their dose modified. The total average amount of the cancer drug received was 8.5, 10.5, and 7.0 mg/kg across the three groups. The reported data also shows results for how long it took before some participants needed a special protective contact lens: this was not applicable for the Standard Steroids group, while the average time was around 3.6 months and 2.1 months for the other two groups. The data for the untreated fourth group was not reported for most outcome measures. Given the very small numbers of participants and the low completion rates, these figures should be interpreted with considerable caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Brain Cancer Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been newly diagnosed with a specific type of brain tumor called glioblastoma (Grade IV GBM or Grade IV gliosarcoma), confirmed by a biopsy or tissue sample
- Your tumor shows a specific genetic change called EGFR amplification (your doctor can check this from your tumor sample)
- Your tumor is located in the upper part of the brain (above the area called the brainstem)
- You have recovered well from your brain surgery, with no serious infections, complications, or significant bleeding afterward
- You are in reasonably good physical condition, able to care for yourself and carry out normal activities (measured by a scoring system your doctor uses)
- Your blood tests show that your bone marrow, kidneys, and liver are working adequately
- A heart tracing (ECG/EKG) done within the past 21 days shows no signs of a heart attack or serious heart problem
- Your doctor expects you to live for at least 3 more months
Who may not be able to join:
- You have previously had chemotherapy or radiation therapy for a cancer in your head or neck area
- You have previously been treated with a type of chemotherapy implanted directly into the brain (such as Gliadel wafers) or any other treatment placed inside the tumor or surgical cavity
- You have a known allergy or serious reaction to the chemotherapy drugs temozolomide or dacarbazine
- You have received any cancer treatment (including chemotherapy, immunotherapy, radiation, hormone therapy, or an experimental treatment) within the past 5 years
- You have serious, uncontrolled health conditions as defined by the study team (confirm with trial site)
- Your doctor believes your overall health makes the risks of being in this trial too high for you
- You have had another active cancer in the past 3 years, unless it was considered fully cured or was a common non-serious type of skin cancer
- You have a history of a herpes infection affecting your eyes (called herpetic keratitis)
- You have certain eye conditions that would make it unsafe for you to use steroid eye drops (confirm with trial site)
- You have had laser eye surgery (such as LASIK) in the past year, or cataract surgery in the past 3 months
- You have an eye condition that makes it difficult to accurately measure your vision or affects your ability to perform everyday visual tasks
- You currently have a hepatitis B or hepatitis C infection
- You are HIV-positive and are not currently receiving HIV treatment medication (antiretroviral therapy)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: AbbVie Inc., AbbVie
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.