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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573324
Recruitment Status : Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE October 9, 2015
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE December 7, 2015
Estimated Primary Completion Date July 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2015)
  • 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.
Change History Complete list of historical versions of study NCT02573324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2015)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioblastoma
  • Gliosarcoma
Intervention  ICMJE
  • Drug: Temozolomide
    oral
  • Drug: ABT-414
    intravenous infusion
    Other Names:
    • Depatuxizumab
    • Mafodotin
  • Radiation: Radiation
  • Drug: Placebo for ABT-414
    intravenous infusion
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 23, 2019)
691
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2015)
720
Estimated Study Completion Date  ICMJE July 18, 2020
Estimated Primary Completion Date July 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location Countries Czech Republic,   Japan
 
Administrative Information
NCT Number  ICMJE NCT02573324
Other Study ID Numbers  ICMJE M13-813
2015-001166-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Radiation Therapy Oncology Group
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date July 2019

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