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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: July 26, 2016
Last verified: July 2016

February 5, 2013
July 26, 2016
April 2013
January 2017   (final data collection date for primary outcome measure)
  • 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
  • Safety (Number of subjects with adverse events and/or dose limiting toxicities) [ Time Frame: Every week for an expected average of 34 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of clinical lab testing, adverse event monitoring, and evaluation of vital signs, physical exam, and electrocardiogram (ECG) (periodic)
  • Pharmacokinetic profile (Arm A and Expanded Cohort) [ Time Frame: Multiple timepoints in Week 1 through Week 9 and then throughout maintenance cycles until end of treatment, an expected average of 34 weeks ] [ Designated as safety issue: Yes ]
    Cmax, Cmin, and half-life
  • Pharmacokinetics (Arm B) [ Time Frame: Multiple timepoints 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 ]
    Cmax, Cmin, and half-life
Complete list of historical versions of study NCT01800695 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
  • 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 A
    ABT-414 in combination with radiation and temozolomide
    Interventions:
    • Drug: ABT-414
    • Drug: Temozolomide
    • Radiation: Whole Brain Radiation
  • Experimental: Arm B
    ABT-414 in combination with temozolomide
    Interventions:
    • Drug: ABT-414
    • Drug: Temozolomide
  • Experimental: Arm C
    ABT-414 monotherapy
    Intervention: Drug: ABT-414
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
196
January 2017
January 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Netherlands
 
NCT01800695
M12-356, 2012-003884-23
No
Not Provided
Not Provided
AbbVie
AbbVie
Not Provided
Study Director: Earle Bain, MD AbbVie
AbbVie
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP