Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590263
• Other study ID #: M13-714
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 24, 2015
• Est. completion date: August 27, 2020

Study information

• Verified date: September 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 27, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme
• Glioma
• Malignant Glioma

Intervention

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.
• ABT-414
ABT-414 will be administered by intravenous infusion

Locations

Country	Name	City	State
Japan	Chiba Cancer Center /ID# 164375	Chiba
Japan	National Cancer Center Hospital /ID# 140435	Chuo-ku	Tokyo
Japan	Saitama Medical University International Medical Center /ID# 140361	Hidaka-shi	Saitama
Japan	Hiroshima University Hospital /ID# 139399	Hiroshima-shi	Hiroshima
Japan	Nihon University Itabashi Hospital /ID# 149385	Itabashi-ku	Tokyo
Japan	Kumamoto University Hospital /ID# 138558	Kumamoto-shi	Kumamoto
Japan	NHO Kyoto Medical Center /ID# 140437	Kyoto
Japan	Kyoto Prefect Univ Med /ID# 149093	Kyoto-shi	Kyoto
Japan	Kyoto University Hospital /ID# 163206	Kyoto-shi	Kyoto
Japan	Kyorin University Hospital /ID# 140360	Mitaka-shi	Tokyo
Japan	Nagoya University Hospital /ID# 138559	Nagoya-shi	Aichi
Japan	Okayama University Hospital /ID# 148674	Okayama-shi	Okayama
Japan	Osaka International Cancer Institute /ID# 148494	Osaka
Japan	Kitasato University Hospital /ID# 148493	Sagamihara-shi	Kanagawa
Japan	Hokkaido University Hospital /ID# 150589	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 138464	Sendai-shi	Miyagi
Japan	Dokkyo Medical University Hospital /ID# 150990	Shimotsuga-gun	Tochigi
Japan	Tokyo Women's Medical University Hospital /ID# 140436	Shinjuku-ku	Tokyo
Japan	Iwate Medical University Hospital /ID# 149145	Shiwa-gun	Iwate
Japan	Osaka University Hospital /ID# 140438	Suita-shi	Osaka
Japan	Shizuoka Cancer Center /ID# 148673	Sunto-gun	Shizuoka
Japan	University of Tsukuba Hospital /ID# 140433	Tsukuba-shi	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with adverse events		At each visit for approximately 4 years
Primary	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.	At each visit for approximately 1 year
Primary	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).	At each visit for approximately 1 year
Primary	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.	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
Primary	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.	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	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).	At each visit for approximately 1 year
Secondary	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).	At each visit for approximately 1 year
Secondary	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).	At each visit for approximately 1 year