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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 July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01800695
First received: February 5, 2013
Last updated: July 10, 2014
Last verified: July 2014

February 5, 2013
July 10, 2014
April 2013
September 2015   (final data collection date for primary outcome measure)
  • 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 A) [ 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, Arm C, Expanded Cohort B and Expanded Cohort C) [ 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
Same as current
Complete list of historical versions of study NCT01800695 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.
 
Recruiting
96
March 2016
September 2015   (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. For Arm A, subject has newly diagnosed GBM and prior surgical resection
  5. For Arm B, subject has newly diagnosed GBM and has completed adjuvant radiation and/or temozolomide therapy or has recurrent GBM per RANO Criteria
  6. For Arm C, subject has recurrent GBM per RANO Criteria

Exclusion Criteria:

  1. For subjects with newly diagnosed GBM, subject has received prior chemotherapy or radiotherapy for cancer of head and neck region
  2. For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
  3. For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
  4. Allergies to temozolomide, dacarbazine, IgG containing agents
  5. Anti-cancer treatment 28 days prior to study Day 1
Both
18 Years and older
No
Contact: Erica Gomez, BA 847-936-1343 erica.gomez@abbvie.com
Contact: JuDee Fischer, BA 8479382512 judee.fischer@abbvie.com
United States,   Australia,   Netherlands
 
NCT01800695
M12-356, 2012-003884-23
No
AbbVie
AbbVie
Not Provided
Study Director: Kyle Holen, MD AbbVie
AbbVie
July 2014

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