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Completed

NCT Number: NCT02590263

Study Evaluating 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.

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Key information

Conditions

Malignant Glioma Astrocytoma Glioblastoma Glioblastoma Multiforme Glioma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Nagoya University Hospital /ID# 138559, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole Brain Radiation

Radiation

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

Temozolomide

Drug

Temozolomide will be administered per label.

ABT-414

Drug

ABT-414 will be administered by intravenous infusion

Other names: Depatuxizumab, Mafodotin

Primary outcomes

  1. Percentage of participants with adverse events

    Time frame: At each visit for approximately 4 years

  2. Number of Dose Limiting Toxicities

    Time frame: At each visit for approximately 1 year

    Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.

  3. Progression-free survival

    Time frame: At each visit for approximately 1 year

    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).

  4. Area under the plasma concentration-time curve (AUC) of ABT-414

    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

    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.

  5. Maximum plasma concentration (Cmax) of ABT-414

    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

    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 outcomes

  1. Objective Response Rate

    Time frame: At each visit for approximately 1 year

    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).

  2. Overall Survival

    Time frame: At each visit for approximately 1 year

    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).

  3. Duration of Overall Response

    Time frame: At each visit for approximately 1 year

    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).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2015
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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