drugset / Trial / NCT01800695
Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.
Timeline
- Start
- 2013-04-02
- Primary completion
- 2017-06-19
- Completion
- 2017-06-19
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Depatuxizumab mafodotin | Other / unclassified | 0.5 mg/kg | Intravenous |
| Subject | Depatuxizumab mafodotin | Other / unclassified | 1.5 mg/kg | Intravenous |
| Background | Temozolomide | Small molecule | 150 mg/m2 | — |
| Background | Temozolomide | Small molecule | 200 mg/m2 | — |