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UNITE Study: Understanding New Interventions With GBM ThErapy

Primary Purpose

Glioblastoma Multiforme

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Steroid eye drops
Vasoconstrictor eye drops
Cold compress
Ophthalmic steroid ointment
Depatuxizumab mafodotin
Temozolomide
Radiation
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Glioblastoma Multiforme (GBM), Cancer, Chemoradiation therapy, Epidermal growth factor receptor-amplified glioblastoma, Radiation, Temozolomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Usc /Id# 164235
  • Moffitt Cancer Center /ID# 164234
  • Rush University Medical Center /ID# 171003
  • Northshore University Health System-Evanston /ID# 164221
  • CDH-Delnor Health System /ID# 169909
  • Columbia University Medical Center /ID# 164220
  • Levine Cancer Ins, Carolina Me /ID# 171271
  • UT Health Science Ctr-Houston /ID# 164223
  • Baylor Scott & White Medical Center- Temple /ID# 170792
  • Royal North Shore Hospital /ID# 169673
  • Calvary Mater Newcastle /ID# 169672
  • Royal Brisbane and Women's Hospital /ID# 169674
  • Austin Hospital /ID# 169671
  • Universitaetsklinik Heidelberg /ID# 169970
  • Universitaetsklinikum Leipzig /ID# 169969
  • Klinikum Univ. Regensburg /ID# 169963
  • Universitatsklinikum Tubingen /ID# 169965
  • Vrije Universiteit Medisch Centrum /ID# 170152
  • Universitair Medisch Centrum Utrecht /ID# 170149
  • Guy's and St Thomas' NHS Found /ID# 207752
  • Queen Elizabeth Hospital - BIRMINGHAM /ID# 200657
  • Castle Hill Hospital /ID# 200662

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Standard Steroids

Standard Steroids + Vasoconstrictor + Cold Compress

Enhanced Steroids + Vasoconstrictor + Cold Compress

Arm Description

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

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).

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).

Outcomes

Primary Outcome Measures

Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management
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.

Secondary Outcome Measures

Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale
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.
Time to Bandage Contact Lens (BCL) Intervention
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.
Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE)
Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs.
Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment
The cumulative dose of depatuxizumab mafodotin administered was tabulated.
Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit
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).
Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention
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.
Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention
Recovery was defined as return to <3-line decline from baseline (≤ +0.3 LogMAR) in visual acuity after BCL intervention.
Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs after BCL intervention.
Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
The time to restart depatuxizumab mafodotin treatment if it was interrupted due to ocular side effects after BCL Intervention was tabulated.
Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention
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).
Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility)
The time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility) was to be recorded.
Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption
The time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin was to be recorded.

Full Information

First Posted
January 26, 2018
Last Updated
March 19, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03419403
Brief Title
UNITE Study: Understanding New Interventions With GBM ThErapy
Official Title
Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because clinical development of depatuxizumab mafodotin in glioblastoma was stopped due to lack of survival benefit.
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Glioblastoma Multiforme (GBM), Cancer, Chemoradiation therapy, Epidermal growth factor receptor-amplified glioblastoma, Radiation, Temozolomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Steroids
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Steroids + Vasoconstrictor + Cold Compress
Arm Type
Experimental
Arm Description
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).
Arm Title
Enhanced Steroids + Vasoconstrictor + Cold Compress
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Steroid eye drops
Intervention Description
Solution, eye drop
Intervention Type
Drug
Intervention Name(s)
Vasoconstrictor eye drops
Intervention Description
Solution, eye drop
Intervention Type
Other
Intervention Name(s)
Cold compress
Intervention Description
Cold compress
Intervention Type
Drug
Intervention Name(s)
Ophthalmic steroid ointment
Intervention Description
Ointment
Intervention Type
Drug
Intervention Name(s)
Depatuxizumab mafodotin
Other Intervention Name(s)
ABT-414
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management
Description
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.
Time Frame
Within 8 weeks after the initial dose of depatuxizumab mafodotin
Secondary Outcome Measure Information:
Title
Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale
Description
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.
Time Frame
Within 8 weeks after the initial dose of depatuxizumab mafodotin
Title
Time to Bandage Contact Lens (BCL) Intervention
Description
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.
Time Frame
Up to 9 months after the first dose of depatuxizumab mafodotin
Title
Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE)
Description
Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs.
Time Frame
From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Title
Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment
Description
The cumulative dose of depatuxizumab mafodotin administered was tabulated.
Time Frame
Up to 9 months
Title
Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit
Description
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).
Time Frame
Up to 47 weeks
Title
Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention
Description
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.
Time Frame
From the last assessment prior to BCL intervention to 2 weeks after BCL intervention
Title
Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention
Description
Recovery was defined as return to <3-line decline from baseline (≤ +0.3 LogMAR) in visual acuity after BCL intervention.
Time Frame
From the last assessment prior to BCL intervention to the end of BCL intervention
Title
Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Description
Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs after BCL intervention.
Time Frame
From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Title
Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Description
The time to restart depatuxizumab mafodotin treatment if it was interrupted due to ocular side effects after BCL Intervention was tabulated.
Time Frame
From the last assessment prior to BCL intervention to the end of BCL intervention
Title
Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention
Description
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).
Time Frame
From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Title
Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility)
Description
The time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility) was to be recorded.
Time Frame
From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Title
Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption
Description
The time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin was to be recorded.
Time Frame
Up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Usc /Id# 164235
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Moffitt Cancer Center /ID# 164234
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Facility Name
Rush University Medical Center /ID# 171003
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Northshore University Health System-Evanston /ID# 164221
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CDH-Delnor Health System /ID# 169909
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Columbia University Medical Center /ID# 164220
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Facility Name
Levine Cancer Ins, Carolina Me /ID# 171271
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
UT Health Science Ctr-Houston /ID# 164223
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Scott & White Medical Center- Temple /ID# 170792
City
Temple
State/Province
Texas
ZIP/Postal Code
76508-0001
Country
United States
Facility Name
Royal North Shore Hospital /ID# 169673
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Calvary Mater Newcastle /ID# 169672
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital /ID# 169674
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Austin Hospital /ID# 169671
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Universitaetsklinik Heidelberg /ID# 169970
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum Leipzig /ID# 169969
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Univ. Regensburg /ID# 169963
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Universitatsklinikum Tubingen /ID# 169965
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Vrije Universiteit Medisch Centrum /ID# 170152
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 170149
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Guy's and St Thomas' NHS Found /ID# 207752
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital - BIRMINGHAM /ID# 200657
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Castle Hill Hospital /ID# 200662
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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UNITE Study: Understanding New Interventions With GBM ThErapy

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