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UNITE Study: Understanding New Interventions With GBM ThErapy

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03419403
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 AbbVie Inc.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Terminated
Countries Australia, Germany, Netherlands, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Additional Details

This Phase 3b open-label, randomized, exploratory study included 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ). All participants received depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids; standard steroids with vasoconstrictors and cold compress; and enhanced steroids with vasoconstrictors and cold compress. The study comprised a screening period of up to 7 weeks after surgery, a 6-week concomitant Chemoradiation Phase, an Adjuvant Phase beginning approximately 4 weeks after completion of chemoradiation, and a Follow-Up Phase.

Arms & Interventions

Arms

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).

Interventions

Drug: - Steroid eye drops

Solution, eye drop

Drug: - Vasoconstrictor eye drops

Solution, eye drop

Other: - Cold compress

Cold compress

Drug: - Ophthalmic steroid ointment

Ointment

Drug: - 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.

Drug: - 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.

Radiation: - Radiation

Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Usc /Id# 164235, Los Angeles, California

Status

Address

Usc /Id# 164235

Los Angeles, California, 90033

Moffitt Cancer Center /ID# 164234, Tampa, Florida

Status

Address

Moffitt Cancer Center /ID# 164234

Tampa, Florida, 33612-9416

Chicago, Illinois

Status

Address

Rush University Medical Center /ID# 171003

Chicago, Illinois, 60612

Evanston, Illinois

Status

Address

Northshore University Health System-Evanston /ID# 164221

Evanston, Illinois, 60201

CDH-Delnor Health System /ID# 169909, Warrenville, Illinois

Status

Address

CDH-Delnor Health System /ID# 169909

Warrenville, Illinois, 60555

New York, New York

Status

Address

Columbia University Medical Center /ID# 164220

New York, New York, 10032-3729

Charlotte, North Carolina

Status

Address

Levine Cancer Ins, Carolina Me /ID# 171271

Charlotte, North Carolina, 28204

Houston, Texas

Status

Address

UT Health Science Ctr-Houston /ID# 164223

Houston, Texas, 77030

Temple, Texas

Status

Address

Baylor Scott & White Medical Center- Temple /ID# 170792

Temple, Texas, 76508-0001

International Sites

Royal North Shore Hospital /ID# 169673, Saint Leonards, New South Wales, Australia

Status

Address

Royal North Shore Hospital /ID# 169673

Saint Leonards, New South Wales, 2065

Calvary Mater Newcastle /ID# 169672, Waratah, New South Wales, Australia

Status

Address

Calvary Mater Newcastle /ID# 169672

Waratah, New South Wales, 2298

Herston, Queensland, Australia

Status

Address

Royal Brisbane and Women's Hospital /ID# 169674

Herston, Queensland, 4029

Austin Hospital /ID# 169671, Heidelberg, Victoria, Australia

Status

Address

Austin Hospital /ID# 169671

Heidelberg, Victoria, 3084

Heidelberg, Baden-Wuerttemberg, Germany

Status

Address

Universitaetsklinik Heidelberg /ID# 169970

Heidelberg, Baden-Wuerttemberg, 69120

Leipzig, Sachsen, Germany

Status

Address

Universitaetsklinikum Leipzig /ID# 169969

Leipzig, Sachsen, 04103

Klinikum Univ. Regensburg /ID# 169963, Regensburg, Germany

Status

Address

Klinikum Univ. Regensburg /ID# 169963

Regensburg, , 93042

Tuebingen, Germany

Status

Address

Universitatsklinikum Tubingen /ID# 169965

Tuebingen, , 72076

Amsterdam, Netherlands

Status

Address

Vrije Universiteit Medisch Centrum /ID# 170152

Amsterdam, , 1081 HV

Utrecht, Netherlands

Status

Address

Universitair Medisch Centrum Utrecht /ID# 170149

Utrecht, , 3584 CX

London, London, City Of, United Kingdom

Status

Address

Guy's and St Thomas' NHS Found /ID# 207752

London, London, City Of, SE1 9RT

Birmingham, United Kingdom

Status

Address

Queen Elizabeth Hospital - BIRMINGHAM /ID# 200657

Birmingham, , B15 2TH

Castle Hill Hospital /ID# 200662, Cottingham, United Kingdom

Status

Address

Castle Hill Hospital /ID# 200662

Cottingham, , HU16 5JQ

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