A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

CompletadoFase 3ClinicalTrials.gov

ID: NCT02573324Tipo: INTERVENTIONALInicio: 4 de ene de 2015Fin estimado: 4 de abr de 2022

Traducción no disponible, mostrando original

Resumen

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

Must have a clinical diagnosis of glioblastoma (GBM).
Must have a confirmed epidermal growth factor receptor amplification in tumor tissue.
Must have a Karnofsky Performance Status (KPS) \>= 70 at assessment \<= 14 days prior to randomization (N/A to the sub-study).
Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment).

Criterios de exclusión

Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM).
Prior chemo therapy or radiosensitizer for head and neck cancer.
Prior radiotherapy to the head or neck in overlap of radiation fields.
Prior therapy for glioblastoma or other invasive malignancy.
Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

Intervenciones

drug

Temozolomide

Oral Capsule

drug

Depatuxizumab mafodotin

Intravenous (IV) Infusion

radiation

Radiation

drug

Placebo for ABT-414

IV Infusion (IV)

Ubicaciones

Sanatorio Parque /ID# 142825

Rosario, Santa Fe Province, Argentina

Duplicate_Instituto Med Alex Flem /ID# 142884

Buenos Aires, Argentina

Patrocinadores

PrincipalAbbVie

ColaboradorRadiation Therapy Oncology Group

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