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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003884-23 | EudraCT Number |
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This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | ABT-414 in combination with radiation and temozolomide |
|
| Arm B | Experimental | ABT-414 in combination with temozolomide |
|
| Arm C | Experimental | ABT-414 monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-414 | Drug | ABT-414 will be administered by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of participants with adverse events | Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG) | Every week for an expected average of 34 weeks |
| Maximum concentration of ABT-414 | Measurement of the maximum concentration of ABT- 414 in the blood | 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 |
| Number of Dose Limiting Toxicities | Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG) | Every week for an expected average of 34 weeks |
| Minimum Concentration of ABT-414 | Measurement of the minimum concentration of ABT-414 in the blood | 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 |
| Half-life of ABT-414 | Measurement of the clearance of ABT-414 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker EGFR expression | Assessment of tumor biomarkers that may correlate with efficacy. | At screening and post-study |
| Progression Free Survival | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Earle Bain, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30796037 | Derived | 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. | |
| 29982805 |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C000620234 | ABT-414 |
| C000631685 | depatuxizumab mafodotin |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Temozolomide | Drug | Temozolomide will be administered per label and local prescribing regulations. |
|
| Whole Brain Radiation | Radiation | Whole Brain radiation will be administered in 30 fractions. |
|
| 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. |
| Overall Survival | The overall response rate will be evaluated every 8 weeks at each assessment of disease according to RANO criteria, up to 28 months | 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 |
| Derived |
| 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. |
| 29533458 | Derived | 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. |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |