Clinical Trials /

Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

NCT01800695

Description:

This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With <span class="go-doc-concept go-doc-disease">Glioblastoma</span> Multiforme

Title

  • Brief Title: Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
  • Official Title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
  • Clinical Trial IDs

    NCT ID: NCT01800695

    ORG ID: M12-356

    NCI ID: 2012-003884-23

    Trial Conditions

    Glioblastoma Multiforme

    Trial Interventions

    Drug Synonyms Arms
    ABT-414 Arm A, Arm B, Arm C
    Temozolomide Arm A, Arm B

    Trial Purpose

    This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with
    glioblastoma multiforme.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm A Experimental ABT-414 in combination with radiation and temozolomide ABT-414, Temozolomide
    Arm B Experimental ABT-414 in combination with temozolomide ABT-414, Temozolomide
    Arm C Experimental ABT-414 monotherapy ABT-414

    Eligibility Criteria

    Inclusion Criteria: 1) Glioblastoma Multiforme (GBM)

    2) 70 or above on Karnofsky Performance Status

    3) Adequate bone marrow function

    4) Recurrent GBM per RANO criteria

    5) Subjects must have confirmed EGFR amplification by central lab

    Exclusion Criteria: 1) For Subjects with recurrent GBM in Arm B, subject has received
    prior treatment with bevacizumab, nitrosourea, or has secondary GBM

    2) For Subjects with recurrent GBM in Arm C, subject has received prior treatment with
    bevacizumab, or has secondary GBM

    3) Allergies to temozolomide, dacarbazine, IgG containing agents

    4) Anti-cancer treatment 28 days prior to study Day 1

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 99 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Number and percentage of participants with adverse events

    Maximum concentration of ABT-414

    Number of Dose Limiting Toxicities

    Minimum Concentration of ABT-414

    Half-life of ABT-414

    Secondary Outcome Measures

    Biomarker EGFR expression

    Progression Free Survival

    Overall Survival

    Trial Keywords

    GBM