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Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

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: NCT02590263
Recruitment Status : Active, not recruiting
First Posted : October 29, 2015
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE October 29, 2015
Last Update Posted Date May 28, 2019
Actual Study Start Date  ICMJE August 24, 2015
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Percentage of participants with adverse events [ Time Frame: At each visit for approximately 4 years ]
  • Number of Dose Limiting Toxicities [ Time Frame: At each visit for approximately 1 year ]
    Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.
  • Progression-free survival [ Time Frame: At each visit for approximately 1 year ]
    Time to progression-free survival is defined as the number of days from the date of first dose 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 (except Arm B and Arm C of Phase 1 portion).
  • Area under the plasma concentration-time curve (AUC) of ABT-414 [ Time Frame: Multiple time points in Cycles 1, 2 and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment for approximately 1 year for recurrent subjects and in every week of Day 1 until Week 7 and end of treatment for the newly diagnosed subjects ]
    Assessed during the Phase 1 portion of the study, the area under the plasma concentration-time curve (AUC) is a method of measurement to determine the total exposure of a drug in blood plasma.
  • Maximum plasma concentration (Cmax) of ABT-414 [ Time Frame: Multiple time points in Cycles 1, 2 and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment for approximately 1 year for recurrent subjects and in every week of Day 1 until Week 7 and end of treatment for the newly diagnosed subjects ]
    Assessed during the Phase 1 portion of the study, the maximum plasma concentration (Cmax) is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • Percentage of participants with adverse events [ Time Frame: At each visit for approximately 4 years ]
  • Maximum plasma concentration (Cmax) of ABT-414 [ Time Frame: Multiple time points in Cycles 1, 2 and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment for approximately 1 year ]
    Assessed during the Phase 1 portion of the study, the maximum plasma concentration (Cmax) is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
  • Number of Dose Limiting Toxicities [ Time Frame: At each visit for approximately 1 year ]
    Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.
  • Area under the plasma concentration-time curve (AUC) of ABT-414 [ Time Frame: Multiple time points in Cycles 1, 2 and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 1 year ]
    Assessed during the Phase 1 portion of the study, the area under the plasma concentration-time curve (AUC) is a method of measurement to determine the total exposure of a drug in blood plasma.
  • Progression-free survival [ Time Frame: At each visit for approximately 1 year ]
    Time to progression-free survival is defined as the number of days from the date of first dose 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Objective Response Rate [ Time Frame: At each visit for approximately 1 year ]
    The objective response rate is defined as the proportion of participants with at least one measurable lesion at baseline who achieves a confirmed complete (CR) or partial response (PR) based on RANO criteria (except Arm B and Arm C of Phase 1 portion).
  • Overall Survival [ Time Frame: At each visit for approximately 1 year ]
    Overall survival is defined as number of days from the date of first dose to the date of death for all dosed participants (except Arm B and Arm C of Phase 1 portion).
  • Duration of Overall Response [ Time Frame: At each visit for approximately 1 year ]
    The duration of overall response for a given participant is defined as the number of days from the day the RANO criteria are met for CR or PR (whichever is recorded first) to the date that progressive disease (PD) is objectively documented (based RANO criteria) (except Arm B and Arm C of Phase 1 portion).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • Overall Survival [ Time Frame: At each visit for approximately 1 year ]
    Overall survival is defined as number of days from the date of first dose to the date of death for all dosed participants.
  • Objective Response Rate [ Time Frame: At each visit for approximately 1 year ]
    The objective response rate is defined as the proportion of participants with at least one measurable lesion at baseline who achieves a confirmed complete (CR) or partial response (PR) based on RANO criteria.
  • Duration of Overall Response [ Time Frame: At each visit for approximately 1 year ]
    The duration of overall response for a given participant is defined as the number of days from the day the RANO criteria are met for CR or PR (whichever is recorded first) to the date that progressive disease (PD) is objectively documented (based RANO criteria).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
Official Title  ICMJE A Non-Randomized, Open-Label, Multi-Center Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Japanese Subjects With Malignant Glioma
Brief Summary This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health Organization (WHO) grade III or IV malignant glioma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malignant Glioma
  • Glioblastoma Multiforme
Intervention  ICMJE
  • Radiation: Whole Brain Radiation
    Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.
  • Drug: Temozolomide
    Temozolomide will be administered per label.
  • Drug: ABT-414
    ABT-414 will be administered by intravenous infusion
    Other Names:
    • Depatuxizumab
    • Mafodotin
Study Arms  ICMJE
  • Experimental: Arm A of Phase 1 portion
    ABT-414 administered every other weeks monotherapy
    Intervention: Drug: ABT-414
  • Experimental: Phase 2 portion
    ABT-414 administered every other weeks in combination with temozolomide
    Interventions:
    • Drug: Temozolomide
    • Drug: ABT-414
  • Experimental: Arm C of Phase 1 portion
    ABT-414 administered every other weeks in combination with radiation and temozolomide
    Interventions:
    • Radiation: Whole Brain Radiation
    • Drug: Temozolomide
    • Drug: ABT-414
  • Experimental: Arm B of Phase 1 portion
    ABT-414 administered every other weeks in combination with radiation and temozolomide
    Interventions:
    • Radiation: Whole Brain Radiation
    • Drug: Temozolomide
    • Drug: ABT-414
Publications * Not Provided

*   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)
53
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2015)
45
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese participants with WHO grade III or IV malignant glioma
  • 70 or above on Karnofsky Performance Status in Arm A of Phase 1 portion and Phase 2 portion
  • 80 or above on Karnofsky Performance Status in Arm B and Arm C of Phase 1 portion
  • Adequate bone marrow function
  • Recurrent malignant glioma per RANO criteria in Arm A of Phase 1 portion and Phase 2 portion
  • Histologically proven newly diagnosed malignant glioma in Arm B and Arm C of Phase 1 portion
  • Participants must have confirmed EGFR amplification by central lab in Phase 2 portion

Exclusion Criteria:

  • Anti-cancer treatment 28 days prior to study Day 1 for Arm A of Phase 1 portion and Phase 2 portion (except temozolomide therapy for newly diagnosed treatment for Phase 2 portion)
  • Anti-cancer treatment prior to study Day 1 for Arm B and Arm C of Phase 1 portion
  • Participant has received prior treatment with bevacizumabor, EGFR therapy in Arm A of Phase 1 portion and Phase 2 portion, or for recurrent glioblastoma in Phase 2 portion
  • Participant has a history of major immunologic reaction to any Immunoglobulin G containing agents or component of ABT-414.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02590263
Other Study ID Numbers  ICMJE M13-714
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
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 Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date May 2019

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