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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01800695
First received: February 5, 2013
Last updated: April 11, 2016
Last verified: April 2016
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Measurement of the clearance of ABT-414


Secondary Outcome Measures:
  • Biomarker EGFR expression [ Time Frame: At screening and post-study ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The overall response rate will be evaluated every 8 weeks at each assessment of disease according to RANO criteria, up to 28 months


Estimated Enrollment: 196
Study Start Date: April 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: June 2016 (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
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years
Genders Eligible for Study:   Both
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
Site Reference ID/Investigator# 131879
Birmingham, Alabama, United States, 35294
United States, California
Site Reference ID/Investigator# 137975
Los Angeles, California, United States, 90095-1769
Site Reference ID/Investigator# 129969
San Francisco, California, United States, 94143-0372
United States, Illinois
Site Reference ID/Investigator# 106817
Chicago, Illinois, United States, 60611
Site Reference ID/Investigator# 106816
Evanston, Illinois, United States, 60201
United States, Massachusetts
Site Reference ID/Investigator# 127615
Boston, Massachusetts, United States, 02215
Site Reference ID/Investigator# 95737
Boston, Massachusetts, United States, 02215
United States, Michigan
Site Reference ID/Investigator# 133570
Detroit, Michigan, United States, 48202
United States, New York
Site Reference ID/Investigator# 92313
New York, New York, United States, 10032
United States, Texas
Site Reference ID/Investigator# 94339
Houston, Texas, United States, 77030
Site Reference ID/Investigator# 91153
San Antonio, Texas, United States, 78229
United States, Utah
Site Reference ID/Investigator# 131769
Salt Lake City, Utah, United States, 84112
Australia
Site Reference ID/Investigator# 133368
Brisbane, Australia, 4029
Site Reference ID/Investigator# 133028
Camperdown, Australia, 2050
Site Reference ID/Investigator# 90833
Heidelberg, Australia, 3084
Site Reference ID/Investigator# 132912
St. Leonards, Australia, 2065
Site Reference ID/Investigator# 136172
Westmead, Australia, 2145
Netherlands
Site Reference ID/Investigator# 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 
Study First Received: February 5, 2013
Last Updated: April 11, 2016
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AbbVie:
GBM

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

ClinicalTrials.gov processed this record on May 24, 2016