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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01800695
First received: February 5, 2013
Last updated: July 6, 2017
Last verified: July 2017
  Purpose
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.

Condition Intervention Phase
Glioblastoma Multiforme Drug: ABT-414 Drug: Temozolomide Radiation: Whole Brain Radiation Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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)

  • 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

  • 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)

  • 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

  • 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 Outcome Measures:
  • Biomarker EGFR expression [ Time Frame: At screening and post-study ]
    Assessment of tumor biomarkers that may correlate with efficacy.

  • 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.

  • 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


Enrollment: 202
Actual Study Start Date: April 2, 2013
Study Completion Date: June 19, 2017
Primary Completion Date: June 19, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
ABT-414 in combination with radiation and temozolomide
Drug: ABT-414
ABT-414 will be administered by intravenous infusion
Other Name: 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 Name: 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 Name: Depatuxizumab Mafodotin

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, except in Arm B expanded cohort temozolomide therapy is allowed
  5. Subjects that have had more than one disease recurrence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800695

Locations
United States, Alabama
University of Alabama-Birmingham /ID# 131879
Birmingham, Alabama, United States, 35294
United States, California
UCLA /Id# 137975
Los Angeles, California, United States, 90095-1769
University of California, San Francisco /ID# 129969
San Francisco, California, United States, 94143-0372
United States, Illinois
Northwestern University /ID# 106817
Chicago, Illinois, United States, 60611
NorthShore University HealthSystem /ID# 106816
Evanston, Illinois, United States, 60201
United States, Massachusetts
Dana Farber Cancer Institute /ID# 95737
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital /ID# 127615
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital /ID# 133570
Detroit, Michigan, United States, 48202
United States, New York
Columbia University Medical Center /ID# 92313
New York, New York, United States, 10032
United States, Texas
The University of Texas - MD Anderson Cancer Center /ID# 94339
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics, LLC /ID# 91153
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah /ID# 131769
Salt Lake City, Utah, United States, 84112
Australia
Royal Brisbane and Womens Hospital /ID# 133368
Brisbane, Australia, 4029
Chris O'Brien Lifehouse /ID# 133028
Camperdown, Australia, 2050
Austin Hospital /ID# 90833
Heidelberg, Australia, 3084
Royal North Shore Hospital /ID# 132912
St. Leonards, Australia, 2065
Westmead Hospital /ID# 136172
Westmead, Australia, 2145
Netherlands
Erasmus Medisch Centrum /ID# 92294
Rotterdam, Netherlands, 3075 EA
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Earle Bain, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01800695     History of Changes
Other Study ID Numbers: M12-356
2012-003884-23 ( EudraCT Number )
Study First Received: February 5, 2013
Last Updated: July 6, 2017

Keywords provided by AbbVie:
GBM

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 20, 2017