Clinical trial · Interventional
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
NCT01800695CI-TRIAL-00030471completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-414 | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
| Whole Brain Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- ABT-414 in combination with radiation and temozolomide
- interventionNames
- Drug: ABT-414
- Drug: Temozolomide
- Radiation: Whole Brain Radiation
- type
- EXPERIMENTAL
- label
- Arm B
- description
- ABT-414 in combination with temozolomide
- interventionNames
- Drug: ABT-414
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- Arm C
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDLassman 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. PMID 30796037
- DERIVEDLassman 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. PMID 29982805
- DERIVEDGoss 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. PMID 29533458