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A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

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ClinicalTrials.gov Identifier: NCT02573324
Recruitment Status : Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.

In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.


Condition or disease Intervention/treatment Phase
Glioblastoma Gliosarcoma Drug: Temozolomide Drug: ABT-414 Radiation: Radiation Drug: Placebo for ABT-414 Phase 2 Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 691 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
Actual Study Start Date : December 7, 2015
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ABT-414, Radiation and Radiation/Temozolomide (TMZ)
ABT-414 is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. ABT-414 is given on Day 1 & 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
 Drug: Temozolomide
Oral Capsule

Drug: ABT-414
Intravenous Infusion (IV)
Other Names:
  • Depatuxizumab
  • Mafodotin

Radiation: Radiation
Placebo Comparator: Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 & 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
 Drug: Temozolomide
Oral Capsule

Radiation: Radiation
Drug: Placebo for ABT-414
Intravenous Infusion (IV)


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Quarterly After Treatment Discontinuation for Approximately 4 Years ]
    Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
    PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur.

  2. OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
    Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.

  3. OS for the MGMT Methylated Group [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
    Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.

  4. Time to Deterioration in Symptom Severity Score M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
    The MDASI-BT is a participant self-report or interviewer-administered measure used to assess the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours.

  5. Time to Deterioration in Symptom Interference Score MDASI-BT [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
    The MDASI-BT is a participant self-report or interviewer-administered measure used to assess the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours.

  6. Time to Deterioration in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
    The HVLT-R will assess neurocognitive changes across time.

  7. OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
    Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.

  8. PFS for EGFRvIII-Mutated Tumor Subgroup [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
    PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur.

  9. Number of Adverse Events (AE) [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a clinical diagnosis of Glioblastoma (GBM).
  • Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue.
  • Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study).
  • Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
  • Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment).

Exclusion Criteria:

  • Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM).
  • Prior chemo therapy or radiosensitizer for head and neck cancer.
  • Prior radiotherapy to the head or neck in overlap of radiation fields.
  • Prior therapy for glioblastoma or other invasive malignancy.
  • Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573324


Locations
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Sponsors and Collaborators
AbbVie
Radiation Therapy Oncology Group
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02573324    
Other Study ID Numbers: M13-813
2015-001166-26 ( EudraCT Number )
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
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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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
Keywords provided by AbbVie:
Newly Diagnosed Glioblastoma
Epithelial Growth Factor Receptor (EGFR)
Temozolomide
ABT-414
Radiology Therapy Oncology Group
Antibody Drug Conjugate
 Brain Tumor
Brain Tumor Group
EGFRvIII
EGFR Amplified
First Line Therapy
Brain Cancer
Additional relevant MeSH terms:
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Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Temozolomide
Immunoconjugates
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs