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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A of Phase 1 portion | Experimental | ABT-414 administered every other weeks monotherapy |
|
| Phase 2 portion | Experimental | ABT-414 administered every other weeks in combination with temozolomide |
|
| Arm C of Phase 1 portion | Experimental | ABT-414 administered every other weeks in combination with radiation and temozolomide |
|
| Arm B of Phase 1 portion | Experimental | ABT-414 administered every other weeks in combination with radiation and temozolomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Brain Radiation | Radiation | Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with adverse events | At each visit for approximately 4 years | |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital /ID# 138559 | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Hiroshima University Hospital /ID# 139399 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34609773 | Derived | 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. |
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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.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
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| Temozolomide | Drug | Temozolomide will be administered per label. |
|
| ABT-414 | Drug | ABT-414 will be administered by intravenous infusion |
|
|
| 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 |
| 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 |
| Hiroshima |
| Hiroshima |
| 734-8551 |
| Japan |
| Hokkaido University Hospital /ID# 150589 | Sapporo | Hokkaido | 060-8648 | Japan |
| University of Tsukuba Hospital /ID# 140433 | Tsukuba | Ibaraki | 305-8576 | Japan |
| Iwate Medical University Hospital /ID# 149145 | Shiwa-gun | Iwate | 028-3695 | Japan |
| Kitasato University Hospital /ID# 148493 | Sagamihara-shi | Kanagawa | 252-0375 | Japan |
| Kumamoto University Hospital /ID# 138558 | Kumamoto | Kumamoto | 860-8556 | Japan |
| Kyoto Prefect Univ Med /ID# 149093 | Kyoto | Kyoto | 602-8566 | Japan |
| Kyoto University Hospital /ID# 163206 | Kyoto | Kyoto | 606-8507 | Japan |
| Tohoku University Hospital /ID# 138464 | Sendai | Miyagi | 980-8574 | Japan |
| Okayama University Hospital /ID# 148674 | Okayama | Okayama-ken | 700-8558 | Japan |
| Osaka University Hospital /ID# 140438 | Suita-shi | Osaka | 565-0871 | Japan |
| Saitama Medical University International Medical Center /ID# 140361 | Hidaka-shi | Saitama | 350-1298 | Japan |
| Shizuoka Cancer Center /ID# 148673 | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Dokkyo Medical University Hospital /ID# 150990 | Shimotsuga-gun | Tochigi | 321-0293 | Japan |
| National Cancer Center Hospital /ID# 140435 | Chuo-ku | Tokyo | 104-0045 | Japan |
| Nihon University Itabashi Hospital /ID# 149385 | Itabashi-ku | Tokyo | 173-0032 | Japan |
| Kyorin University Hospital /ID# 140360 | Mitaka-shi | Tokyo | 181-8611 | Japan |
| Tokyo Women's Medical University Hospital /ID# 140436 | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Chiba Cancer Center /ID# 164375 | Chiba | 260-0801 | Japan |
| NHO Kyoto Medical Center /ID# 140437 | Kyoto | 612-0861 | Japan |
| Osaka International Cancer Institute /ID# 148494 | Osaka | 541-8567 | Japan |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| C000620234 | ABT-414 |
| C000604456 | depatuxizumab |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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