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Completed

NCT Number: NCT01800695

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

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

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Key information

Conditions

Glioblastoma Multiforme Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Glioblastoma Multiforme (GBM)
  • 70 or above on Karnofsky Performance Status
  • Adequate bone marrow function
  • Recurrent GBM per RANO criteria
  • Subjects must have confirmed EGFR amplification by central lab

Exclusion criteria

  • For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
  • For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
  • Allergies to temozolomide, dacarbazine, IgG containing agents
  • Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
  • Subjects that have had more than one disease recurrence

Treatment and study plan

ABT-414

Drug

ABT-414 will be administered by intravenous infusion

Other names: Depatuxizumab Mafodotin

Temozolomide

Drug

Temozolomide will be administered per label and local prescribing regulations.

Whole Brain Radiation

Radiation

Whole Brain radiation will be administered in 30 fractions.

Primary outcomes

  1. Number and percentage of participants with adverse events

    Time frame: Every week for an expected average of 34 weeks

    Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)

  2. Maximum concentration 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, an expected average of 34 weeks

    Measurement of the maximum concentration of ABT- 414 in the blood

  3. Number of Dose Limiting Toxicities

    Time frame: Every week for an expected average of 34 weeks

    Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)

  4. Minimum Concentration 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, an expected average of 34 weeks

    Measurement of the minimum concentration of ABT-414 in the blood

  5. Half-life 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, an expected average of 34 weeks

    Measurement of the clearance of ABT-414

Secondary outcomes

  1. Biomarker EGFR expression

    Time frame: At screening and post-study

    Assessment of tumor biomarkers that may correlate with efficacy.

  2. Progression Free Survival

    Time frame: Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or the participant becomes lost to follow up, or study termination.

    Progression Free Survival per RANO criteria is the length of time during and after the treatment of a disease, that the participant lives with the disease but does not get worse.

  3. Overall Survival

    Time frame: Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or participant becomes lost to follow up, or study termination

    The overall response rate will be evaluated every 8 weeks at each assessment of disease according to RANO criteria, up to 28 months

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2013
Registry last updated
Nov 21, 2017

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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