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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01800695
First Posted: February 28, 2013
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800695


Sponsors and Collaborators
AbbVie
Investigators
Study Director: Earle Bain, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01800695     History of Changes
Other Study ID Numbers: M12-356
2012-003884-23 ( EudraCT Number )
First Submitted: February 5, 2013
First Posted: February 28, 2013
Last Update Posted: November 21, 2017
Last Verified: July 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