Trial record 1 of 3 for:    ABT-414
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Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01800695
First received: February 5, 2013
Last updated: March 24, 2015
Last verified: March 2015
  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 II 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: October 2016
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 and older
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
  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

Contacts
Contact: Erica Gomez, BA 847-936-1343 erica.gomez@abbvie.com
Contact: JuDee Fischer, BA 8479382512 judee.fischer@abbvie.com

Locations
United States, California
Site Reference ID/Investigator# 129969 Recruiting
San Francisco, California, United States, 94143-0372
Principal Investigator: Site Reference ID/Investigator# 129969         
United States, Illinois
Site Reference ID/Investigator# 106817 Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Site Reference ID/Investigator# 106817         
Site Reference ID/Investigator# 106816 Recruiting
Evanston, Illinois, United States, 60201
Principal Investigator: Site Reference ID/Investigator# 106816         
United States, Massachusetts
Site Reference ID/Investigator# 127615 Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Site Reference ID/Investigator# 127615         
Site Reference ID/Investigator# 95737 Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Site Reference ID/Investigator# 95737         
United States, New York
Site Reference ID/Investigator# 92313 Recruiting
New York, New York, United States, 10032
Principal Investigator: Site Reference ID/Investigator# 92313         
United States, Texas
Site Reference ID/Investigator# 90773 Recruiting
San Antonio, Texas, United States, 78258
Principal Investigator: Site Reference ID/Investigator# 90773         
United States, Utah
Site Reference ID/Investigator# 131769 Not yet recruiting
Salt Lake City, Utah, United States, 84112
Principal Investigator: Site Reference ID/Investigator# 131769         
Australia
Site Reference ID/Investigator# 133368 Recruiting
Brisbane, Australia, 4029
Principal Investigator: Site Reference ID/Investigator# 133368         
Site Reference ID/Investigator# 90833 Recruiting
Heidelberg, Australia, 3084
Principal Investigator: Site Reference ID/Investigator# 90833         
Site Reference ID/Investigator# 132912 Recruiting
St. Leonards, Australia, 2065
Principal Investigator: Site Reference ID/Investigator# 132912         
Site Reference ID/Investigator# 136172 Not yet recruiting
Westmead, Australia, 2145
Principal Investigator: Site Reference ID/Investigator# 136172         
Netherlands
Site Reference ID/Investigator# 92294 Recruiting
Rotterdam, Netherlands, 3075 EA
Principal Investigator: Site Reference ID/Investigator# 92294         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Kyle Holen, MD AbbVie
  More Information

No publications provided

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: March 24, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug 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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2015