Clinical trial NCT02590263: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Glioma
Glioblastoma Multiforme
Keywords: WHO grade III
WHO grade IV
Glioblastoma
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-10-29
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of participants with adverse events
timeFrame: At each visit for approximately 4 years
measure: Number of Dose Limiting Toxicities
timeFrame: At each visit for approximately 1 year
measure: Progression-free survival
timeFrame: At each visit for approximately 1 year
measure: Area under the plasma concentration-time curve (AUC) of ABT-414
timeFrame: 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
measure: Maximum plasma concentration (Cmax) of ABT-414
timeFrame: 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 outcomes:
measure: Objective Response Rate
timeFrame: At each visit for approximately 1 year
measure: Overall Survival
timeFrame: At each visit for approximately 1 year
measure: Duration of Overall Response
timeFrame: At each visit for approximately 1 year
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital /ID# 138559
state: Aichi
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital /ID# 139399
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 150589
state: Hokkaido
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital /ID# 140433
state: Ibaraki
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital /ID# 149145
state: Iwate
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital /ID# 148493
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital /ID# 138558
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: Kyoto Prefect Univ Med /ID# 149093
state: Kyoto
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 163206
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 138464
state: Miyagi
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 148674
state: Okayama
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 140438
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center /ID# 140361
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 148673
state: Shizuoka
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital /ID# 150990
state: Tochigi
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 140435
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital /ID# 149385
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital /ID# 140360
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital /ID# 140436
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Cancer Center /ID# 164375
city: Kyoto
country: Japan
facility: NHO Kyoto Medical Center /ID# 140437
city: Osaka
country: Japan
facility: Osaka International Cancer Institute /ID# 148494
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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.