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A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 in Combination With Radiation Plus Temozolomide or Temozolomide Alone for Subjects With Glioblastoma Multiforme


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 in Combination With Radiation Plus Temozolomide or Temozolomide Alone for Subjects With Glioblastoma Multiforme


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

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, more than 2 therapies, or has secondary GBM

3. Allergies to temozolomide, dacarbazine, IgG containing agents

4. Anti-cancer treatment 28 days prior to study Day 1

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (Number of subjects with adverse events and/or dose limiting toxicities)

Outcome Description:

Evaluation of clinical lab testing, adverse event monitoring, and evaluation of vital signs, physical exam, and electrocardiogram (ECG) (periodic)

Outcome Time Frame:

Every week for an expected average of 34 weeks

Safety Issue:

Yes

Principal Investigator

Kyle Holen, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

M12-356

NCT ID:

NCT01800695

Start Date:

April 2013

Completion Date:

September 2015

Related Keywords:

  • Glioblastoma Multiforme
  • GBM
  • Glioblastoma

Name

Location

Site Reference ID/Investigator# 90773San Antonio, Texas  78258