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Malignant GliomaPhase 1/2NCT02590263

Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

A Phase 1/2 study testing Whole Brain Radiation, Temozolomide and ABT-414 in people with Malignant Glioma and Glioblastoma Multiforme, run by AbbVie at 22 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 99 years
Conditions the study is for
Malignant Glioma, Glioblastoma Multiforme
What is being tested?
Whole Brain Radiation, Temozolomide and ABT-414
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
22 sitesJapan
Study dates
24 Aug 2015to 27 Aug 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Japan22 sites

  • Chiba Cancer Center /ID# 164375

    Chiba, 260-0801

  • National Cancer Center Hospital /ID# 140435

    Chuo-ku, Tokyo, 104-0045

  • Saitama Medical University International Medical Center /ID# 140361

    Hidaka-shi, Saitama, 350-1298

  • Hiroshima University Hospital /ID# 139399

    Hiroshima, Hiroshima, 734-8551

  • Kumamoto University Hospital /ID# 138558

    Kumamoto, Kumamoto, 860-8556

  • Kyoto Prefect Univ Med /ID# 149093

    Kyoto, Kyoto, 602-8566

  • Kyoto University Hospital /ID# 163206

    Kyoto, Kyoto, 606-8507

  • NHO Kyoto Medical Center /ID# 140437

    Kyoto, 612-0861

  • Kyorin University Hospital /ID# 140360

    Mitaka-shi, Tokyo, 181-8611

  • Nagoya University Hospital /ID# 138559

    Nagoya, Aichi-ken, 466-8560

  • Okayama University Hospital /ID# 148674

    Okayama, Okayama-ken, 700-8558

  • Osaka International Cancer Institute /ID# 148494

    Osaka, 541-8567

  • Kitasato University Hospital /ID# 148493

    Sagamihara-shi, Kanagawa, 252-0375

  • Hokkaido University Hospital /ID# 150589

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital /ID# 138464

    Sendai, Miyagi, 980-8574

  • Dokkyo Medical University Hospital /ID# 150990

    Shimotsuga-gun, Tochigi, 321-0293

  • Tokyo Women's Medical University Hospital /ID# 140436

    Shinjuku-ku, Tokyo, 162-8666

  • Iwate Medical University Hospital /ID# 149145

    Shiwa-gun, Iwate, 028-3695

  • Osaka University Hospital /ID# 140438

    Suita-shi, Osaka, 565-0871

  • Shizuoka Cancer Center /ID# 148673

    Sunto-gun, Shizuoka, 411-8777

  • Nihon University Itabashi Hospital /ID# 149385

    tabashi City, Tokyo, 173-0032

  • University of Tsukuba Hospital /ID# 140433

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

About this study

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

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.

Being tested
Whole Brain Radiation, Temozolomide, ABT-414
Keywords
WHO grade III, WHO grade IV, Glioblastoma
Medical subject headings
Glioma, Glioblastoma, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole Brain RadiationRadiation

    Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.

  • TemozolomideDrug

    Temozolomide will be administered per label.

  • ABT-414Drug

    Also called Depatuxizumab, Mafodotin

    ABT-414 will be administered by intravenous infusion

Study groups in NCT02590263
Study groupRoleWhat they receive
Arm A of Phase 1 portionExperimentalABT-414 administered every other weeks monotherapy
Receives: Drug: ABT-414
Phase 2 portionExperimentalABT-414 administered every other weeks in combination with temozolomide
Receives: Drug: Temozolomide; Drug: ABT-414
Arm C of Phase 1 portionExperimentalABT-414 administered every other weeks in combination with radiation and temozolomide
Receives: Radiation: Whole Brain Radiation; Drug: Temozolomide; Drug: ABT-414
Arm B of Phase 1 portionExperimentalABT-414 administered every other weeks in combination with radiation and temozolomide
Receives: Radiation: Whole Brain Radiation; Drug: Temozolomide; Drug: ABT-414

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with adverse events

    Measured: At each visit for approximately 4 years

  2. 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.

    Measured: At each visit for approximately 1 year

  3. 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).

    Measured: At each visit for approximately 1 year

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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 (3)

  1. 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).

    Measured: At each visit for approximately 1 year

  2. 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).

    Measured: At each visit for approximately 1 year

  3. 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).

    Measured: At each visit for approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2015 (estimated)
  2. Study start24 Aug 2015
  3. Primary completion27 Aug 2020
  4. Study completion27 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02590263
Sponsor's protocol ID
M13-714
Status last verified
Sep 2020
First submitted
28 Sep 2015
Last updated
3 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34609773

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Whole Brain Radiation, Temozolomide and ABT-414 in people with Malignant Glioma and Glioblastoma Multiforme, run by AbbVie at 22 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with adverse events (time frame: At each visit for approximately 4 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02590263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.

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