ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02573324
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
AbbVie

September 28, 2015
October 9, 2015
September 7, 2018
December 7, 2015
March 18, 2020   (Final data collection date for primary outcome measure)
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.
  • 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.
Complete list of historical versions of study NCT02573324 on ClinicalTrials.gov Archive Site
  • OS for the O6-methylguaninemethlytransferese (MGMT) methylated 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.
  • 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.
  • 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.
  • Number of days to deterioration in neurocognitive functioning on the Hopkins Verbal Learning Test Revised (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.
  • Progression Free Survival (PFS) [ 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 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.
  • 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.
  • 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 neurocognitive functioning [ 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 0.5 SD or greater deterioration from baseline on the composite score of the Clinical Trial Battery.
  • 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.
Not Provided
Not Provided
 
A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
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)

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.

The main study for all countries except China is closed. The sub-study of ABT-414 (number of participants being sought=12) in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment is open to enrollment.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Glioblastoma Multiforme
  • Gliosarcoma
  • Drug: Temozolomide
    oral
  • Drug: ABT-414
    intravenous infusion
    Other Names:
    • Depatuxizumab
    • Mafodotin
  • Radiation: Radiation
  • Drug: Placebo for ABT-414
    intravenous infusion
  • 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.
    Interventions:
    • Drug: Temozolomide
    • Radiation: Radiation
    • Drug: Placebo for ABT-414
  • 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.
    Interventions:
    • Drug: Temozolomide
    • Drug: ABT-414
    • Radiation: Radiation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
640
720
February 13, 2021
March 18, 2020   (Final data collection date for primary outcome measure)

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) >= 70 at assessment <= 14 days prior to randomization (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 gliomatosis 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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Older Adult)
No
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Colombia,   Czechia,   France,   Germany,   Hong Kong,   Ireland,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Czech Republic,   Japan
 
NCT02573324
M13-813
2015-001166-26 ( EudraCT Number )
Yes
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
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
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
AbbVie
AbbVie
Radiation Therapy Oncology Group
Study Director: AbbVie Inc. AbbVie
AbbVie
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP