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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by AbbVie
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02573324
First received: September 28, 2015
Last updated: May 2, 2017
Last verified: May 2017
  Purpose

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in 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 subjects with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.


Condition Intervention Phase
Glioblastoma Gliosarcoma Drug: ABT-414 Radiation: Radiation Drug: Temozolomide Drug: Placebo for ABT-414 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled Phase 2b/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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Progression Free Survival (PFS) for Phase 2b [ Time Frame: At Baseline, then every 8 weeks, at follow up visits and at the final study drug visit, for an average of up to 2 years. ]
    Time to PFS is 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 (as determined by the Investigator) or to the date of death, if disease progression does not occur.

  • Overall Survival (OS) for Phase 3 [ 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:
  • Progression Free Survival (PFS) for Phase 3 [ Time Frame: At Baseline, then every 8 weeks, at follow up visits and at the final study drug visit, for an average of up to 2 years. ]
    Time to PFS is 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 (as determined by the Investigator) or to the date of death, if disease progression does not occur.

  • Overall Survival (OS) for Phase 2b [ 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.

  • OS for the EGFRvIII-mutated tumor subgroup [ 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.

  • PFS for EGFRvIII-mutated tumor subgroup [ Time Frame: At Baseline, then every 8 weeks, at follow up visits and at the final study drug visit, for an average of up to 2 years. ]
    Time to PFS is 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 (as determined by the Investigator) or to the date of death, if disease progression does not occur.

  • Number of days to deterioration in verbal memory (HVLT-R) [ Time Frame: At Screening, every 8 weeks until disease progression, and post-progression, for an average of up to 2 years. ]
    Number of days from baseline to decline using the reliable change index (RCI) criterion based on raw scores.

  • Number of days to deterioration in symptom severity score M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) [ Time Frame: At Screening, every 8 weeks until disease progression, and post-progression, for an average of up to 2 years. ]
    Number of days from baseline to 1 point or greater increase in MDASI-BT symptom severity score.

  • Number of days to deterioration in symptom interference score (MDASI-BT) [ Time Frame: At Screening, every 8 weeks until disease progression, at post-progression, for an average of up to 2 years. ]
    Number of days from baseline to 1 point or greater increase in MDASI-BT symptom interference score.


Estimated Enrollment: 720
Study Start Date: December 22, 2015
Estimated Study Completion Date: April 17, 2020
Estimated Primary Completion Date: March 18, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-414, radiation and 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: ABT-414
intravenous infusion
Other Name: Depatuxizumab Mafodotin
Radiation: Radiation Drug: Temozolomide
oral
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.
Radiation: Radiation Drug: Temozolomide
oral
Drug: Placebo for ABT-414
intravenous infusion

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: 1. Must have a clinical diagnosis of Glioblastoma (GBM) 2. Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue 3. Must have a Karnofsky Performance Status (KPS) performance score of 70 - 100 (N/A to the sub-study) 4. Must have recovered from effects of surgery, postoperative infection and other complications of surgery 5. Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the subject must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment) Exclusion Criteria: 1. Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the sub-study, the subject can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM) 2. Prior chemo therapy or radiosensitizer for head and neck cancer 3. Prior radiotherapy to the head or neck in overlap of radiation fields 4. Prior therapy for glioblastoma or other invasive malignancy 5. Prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02573324

Contacts
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

  Show 204 Study Locations
Sponsors and Collaborators
AbbVie
Radiation Therapy Oncology Group
Investigators
Study Director: Earle Bain, MD AbbVie
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02573324     History of Changes
Other Study ID Numbers: M13-813
2015-001166-26 ( EudraCT Number )
Study First Received: September 28, 2015
Last Updated: May 2, 2017

Keywords provided by AbbVie:
Newly Diagnosed Glioblastoma
Brain Cancer
Temozolomide
EGFR Amplified
Radiology Therapy Oncology Group
ABT-414
EGFRvIII
Antibody Drug Conjugate
Epithelial Growth Factor Receptor
Brain Tumor Group
First Line Therapy
Brain Tumor

Additional relevant MeSH terms:
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
Dacarbazine
Mitogens
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on June 26, 2017