Clinical Trials /

Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

NCT02590263

Description:

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.

Related Conditions:
  • Malignant Glioma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

    <li>Brief Title: Study Evaluating ABT-414 in Japanese Subjects With Malignant Gliomali><li>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 Gliomali>

Clinical Trial IDs

    <li>ORG STUDY ID: M13-714li><li>NCT ID: NCT02590263li>

Conditions

    <li>Malignant Gliomali><li>Glioblastoma Multiformeli>

Interventions

<td>Temozolomidetd><td/><td>Arm B of Phase 1 portiontd><td>ABT-414td><td>Depatuxizumab, Mafodotintd><td>Arm A of Phase 1 portiontd>
DrugSynonymsArms

Purpose

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.

Trial Arms

<td>Arm A of Phase 1 portiontd><td>Experimentaltd><td>ABT-414 administered every other weeks monotherapytd><td>
    <li>ABT-414li>
td><td>Phase 2 portiontd><td>Experimentaltd><td>ABT-414 administered every other weeks in combination with temozolomidetd><td>
    <li>Temozolomideli><li>ABT-414li>
td><td>Arm C of Phase 1 portiontd><td>Experimentaltd><td>ABT-414 administered every other weeks in combination with radiation and temozolomidetd><td>
    <li>Temozolomideli><li>ABT-414li>
td><td>Arm B of Phase 1 portiontd><td>Experimentaltd><td>ABT-414 administered every other weeks in combination with radiation and temozolomidetd><td>
    <li>Temozolomideli><li>ABT-414li>
td>
NameTypeDescriptionInterventions

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 bevacizumab, or 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.
      
<td>Maximum Eligible Age:td><td>99 Yearstd><td>Minimum Eligible Age:td><td>20 Yearstd><td>Eligible Gender:td><td>Alltd><td>Healthy Volunteers:td><td>Notd>

Primary Outcome Measures

<td>Measure:td><td>Percentage of participants with adverse eventstd><td>Time Frame:td><td>At each visit for approximately 4 yearstd><td>Safety Issue:td><td/><td>Description:td><td>Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.td>

Secondary Outcome Measures

<td>Measure:td><td>Objective Response Ratetd><td>Time Frame:td><td>At each visit for approximately 1 yeartd><td>Safety Issue:td><td/><td>Description:td><td>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).td>
<td>Measure:td><td>Overall Survivaltd><td>Time Frame:td><td>At each visit for approximately 1 yeartd><td>Safety Issue:td><td/><td>Description:td><td>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).td>
<td>Measure:td><td>Duration of Overall Responsetd><td>Time Frame:td><td>At each visit for approximately 1 yeartd><td>Safety Issue:td><td/><td>Description:td><td>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).td>

Details

<td>Phase:td><td>Phase 1/Phase 2td><td>Primary Purpose:td><td>Interventionaltd><td>Overall Status:td><td>Recruitingtd><td>Lead Sponsor:td><td>AbbVietd>

Trial Keywords

    <li>WHO grade IIIli><li>WHO grade IVli><li>Glioblastomali>

Last Updated

<p/>