Back to resultsStudy Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
Primary Purpose
Malignant Glioma, Glioblastoma Multiforme
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Whole Brain Radiation
Temozolomide
ABT-414
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Glioma focused on measuring WHO grade III, WHO grade IV, Glioblastoma
Eligibility Criteria
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.
Sites / Locations
- Nagoya University Hospital /ID# 138559
- Hiroshima University Hospital /ID# 139399
- Hokkaido University Hospital /ID# 150589
- University of Tsukuba Hospital /ID# 140433
- Iwate Medical University Hospital /ID# 149145
- Kitasato University Hospital /ID# 148493
- Kumamoto University Hospital /ID# 138558
- Kyoto Prefect Univ Med /ID# 149093
- Kyoto University Hospital /ID# 163206
- Tohoku University Hospital /ID# 138464
- Okayama University Hospital /ID# 148674
- Osaka University Hospital /ID# 140438
- Saitama Medical University International Medical Center /ID# 140361
- Shizuoka Cancer Center /ID# 148673
- Dokkyo Medical University Hospital /ID# 150990
- National Cancer Center Hospital /ID# 140435
- Nihon University Itabashi Hospital /ID# 149385
- Kyorin University Hospital /ID# 140360
- Tokyo Women's Medical University Hospital /ID# 140436
- Chiba Cancer Center /ID# 164375
- NHO Kyoto Medical Center /ID# 140437
- Osaka International Cancer Institute /ID# 148494
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm A of Phase 1 portion
Phase 2 portion
Arm C of Phase 1 portion
Arm B of Phase 1 portion
Arm Description
ABT-414 administered every other weeks monotherapy
ABT-414 administered every other weeks in combination with temozolomide
ABT-414 administered every other weeks in combination with radiation and temozolomide
ABT-414 administered every other weeks in combination with radiation and temozolomide
Outcomes
Primary Outcome Measures
Percentage of participants with adverse events
Number of Dose Limiting Toxicities
Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.
Progression-free survival
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
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
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.
Secondary Outcome Measures
Objective Response Rate
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02590263
Brief Title
Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 24, 2015 (Actual)
Primary Completion Date
August 27, 2020 (Actual)
Study Completion Date
August 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma, Glioblastoma Multiforme
Keywords
WHO grade III, WHO grade IV, Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A of Phase 1 portion
Arm Type
Experimental
Arm Description
ABT-414 administered every other weeks monotherapy
Arm Title
Phase 2 portion
Arm Type
Experimental
Arm Description
ABT-414 administered every other weeks in combination with temozolomide
Arm Title
Arm C of Phase 1 portion
Arm Type
Experimental
Arm Description
ABT-414 administered every other weeks in combination with radiation and temozolomide
Arm Title
Arm B of Phase 1 portion
Arm Type
Experimental
Arm Description
ABT-414 administered every other weeks in combination with radiation and temozolomide
Intervention Type
Radiation
Intervention Name(s)
Whole Brain Radiation
Intervention Description
Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
Temozolomide will be administered per label.
Intervention Type
Drug
Intervention Name(s)
ABT-414
Other Intervention Name(s)
Depatuxizumab, Mafodotin
Intervention Description
ABT-414 will be administered by intravenous infusion
Primary Outcome Measure Information:
Title
Percentage of participants with adverse events
Time Frame
At each visit for approximately 4 years
Title
Number of Dose Limiting Toxicities
Description
Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.
Time Frame
At each visit for approximately 1 year
Title
Progression-free survival
Description
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).
Time Frame
At each visit for approximately 1 year
Title
Area under the plasma concentration-time curve (AUC) of ABT-414
Description
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.
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
Title
Maximum plasma concentration (Cmax) of ABT-414
Description
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.
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
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
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).
Time Frame
At each visit for approximately 1 year
Title
Overall Survival
Description
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).
Time Frame
At each visit for approximately 1 year
Title
Duration of Overall Response
Description
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).
Time Frame
At each visit for approximately 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya University Hospital /ID# 138559
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Hiroshima University Hospital /ID# 139399
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Hokkaido University Hospital /ID# 150589
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
University of Tsukuba Hospital /ID# 140433
City
Tsukuba-shi
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Iwate Medical University Hospital /ID# 149145
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Kitasato University Hospital /ID# 148493
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Kumamoto University Hospital /ID# 138558
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto Prefect Univ Med /ID# 149093
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Kyoto University Hospital /ID# 163206
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Tohoku University Hospital /ID# 138464
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Okayama University Hospital /ID# 148674
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka University Hospital /ID# 140438
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Medical University International Medical Center /ID# 140361
City
Hidaka-shi
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Shizuoka Cancer Center /ID# 148673
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Dokkyo Medical University Hospital /ID# 150990
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
National Cancer Center Hospital /ID# 140435
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Nihon University Itabashi Hospital /ID# 149385
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-0032
Country
Japan
Facility Name
Kyorin University Hospital /ID# 140360
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital /ID# 140436
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Chiba Cancer Center /ID# 164375
City
Chiba
ZIP/Postal Code
260-0801
Country
Japan
Facility Name
NHO Kyoto Medical Center /ID# 140437
City
Kyoto
ZIP/Postal Code
612-0861
Country
Japan
Facility Name
Osaka International Cancer Institute /ID# 148494
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
34609773
Citation
Narita Y, Muragaki Y, Kagawa N, Asai K, Nagane M, Matsuda M, Ueki K, Kuroda J, Date I, Kobayashi H, Kumabe T, Beppu T, Kanamori M, Kasai S, Nishimura Y, Xiong H, Ocampo C, Yamada M, Mishima K. Safety and efficacy of depatuxizumab mafodotin in Japanese patients with malignant glioma: A nonrandomized, phase 1/2 trial. Cancer Sci. 2021 Dec;112(12):5020-5033. doi: 10.1111/cas.15153. Epub 2021 Oct 30.
Results Reference
derived
Learn more about this trial
Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
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