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

November 17, 2017 updated by: AbbVie

A Phase 1 Study 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, except in Arm B expanded cohort temozolomide therapy is allowed
  5. Subjects that have had more than one disease recurrence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
ABT-414 in combination with radiation and temozolomide
Drug: ABT-414
ABT-414 will be administered by intravenous infusion
Other Names:
  • Depatuxizumab Mafodotin
Drug: Temozolomide
Temozolomide will be administered per label and local prescribing regulations.
Radiation: Whole Brain Radiation
Whole Brain radiation will be administered in 30 fractions.
Experimental: Arm B
ABT-414 in combination with temozolomide
Drug: ABT-414
ABT-414 will be administered by intravenous infusion
Other Names:
  • Depatuxizumab Mafodotin
Drug: Temozolomide
Temozolomide will be administered per label and local prescribing regulations.
Experimental: Arm C
ABT-414 monotherapy
Drug: ABT-414
ABT-414 will be administered by intravenous infusion
Other Names:
  • Depatuxizumab Mafodotin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Every week for an expected average of 34 weeks
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
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
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)
Every week for an expected average of 34 weeks
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
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
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker EGFR expression
Time Frame: At screening and post-study
Assessment of tumor biomarkers that may correlate with efficacy.
At screening and post-study
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.
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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: Earle Bain, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2013

Primary Completion (Actual)

June 19, 2017

Study Completion (Actual)

June 19, 2017

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-356
  • 2012-003884-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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