Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
NCT ID: NCT01800695
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
202 participants
INTERVENTIONAL
2013-04-02
2017-06-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
ABT-414 in combination with radiation and temozolomide
ABT-414
ABT-414 will be administered by intravenous infusion
Temozolomide
Temozolomide will be administered per label and local prescribing regulations.
Whole Brain Radiation
Whole Brain radiation will be administered in 30 fractions.
Arm B
ABT-414 in combination with temozolomide
ABT-414
ABT-414 will be administered by intravenous infusion
Temozolomide
Temozolomide will be administered per label and local prescribing regulations.
Arm C
ABT-414 monotherapy
ABT-414
ABT-414 will be administered by intravenous infusion
Interventions
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ABT-414
ABT-414 will be administered by intravenous infusion
Temozolomide
Temozolomide will be administered per label and local prescribing regulations.
Whole Brain Radiation
Whole Brain radiation will be administered in 30 fractions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
99 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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Earle Bain, MD
Role: STUDY_DIRECTOR
AbbVie
Countries
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References
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Lassman AB, Roberts-Rapp L, Sokolova I, Song M, Pestova E, Kular R, Mullen C, Zha Z, Lu X, Gomez E, Bhathena A, Maag D, Kumthekar P, Gan HK, Scott AM, Guseva M, Holen KD, Ansell PJ, van den Bent MJ. Comparison of Biomarker Assays for EGFR: Implications for Precision Medicine in Patients with Glioblastoma. Clin Cancer Res. 2019 Jun 1;25(11):3259-3265. doi: 10.1158/1078-0432.CCR-18-3034. Epub 2019 Feb 22.
Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.
Goss GD, Vokes EE, Gordon MS, Gandhi L, Papadopoulos KP, Rasco DW, Fischer JS, Chu KL, Ames WW, Mittapalli RK, Lee HJ, Zeng J, Roberts-Rapp LA, Loberg LI, Ansell PJ, Reilly EB, Ocampo CJ, Holen KD, Tolcher AW. Efficacy and safety results of depatuxizumab mafodotin (ABT-414) in patients with advanced solid tumors likely to overexpress epidermal growth factor receptor. Cancer. 2018 May 15;124(10):2174-2183. doi: 10.1002/cncr.31304. Epub 2018 Mar 13.
Other Identifiers
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2012-003884-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M12-356
Identifier Type: -
Identifier Source: org_study_id