An Expanded Access Protocol of Oral Rociletinib (CO-1686) as Epidermal Growth Factor Receptor (EGFR)-Directed Therapy for Patients With EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) With the T790M Resistance Mutation
Collecte de données
Néoplasmes bronchiques+7
+ Carcinome du poumon non à petites cellules
+ Carcinome bronchogénique
Suspendu
Éligible sur prescription d’un médecin habilitéRésumé
This is an open-label, multi-center study in the US, which allows for expanded access to rociletinib for patients with advanced or metastatic, EGFR-mutant T790M+ NSCLC who were previously treated with at least one prior EGFR TKI therapy (≥2nd line). Patients will receive oral rociletinib twice daily on study as long as they have clinical benefit and until they have access to FDA-approved rociletinib.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Conditions
Pathologie
Critères
Key Inclusion Criteria: * Unresectable locally advanced or metastatic NSCLC with EGFR activating mutation (excluding exon 20 insertion) and presence of the T790M mutation * Prior treatment with an approved or experimental EGFR-directed therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate hematological and biological function * Written informed consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF before any study-specific evaluation Key Exclusion Criteria: * Eligibility for other enrolling clinical trials of rociletinib * Leptomeningeal carcinomatosis or other untreated or symptomatic CNS metastases (asymptomatic CNS metastases allowed if clinically stable without requirement for steroid dose increase for at least 4 weeks) * History of prior interstitial lung disease * Concurrent use of QT-prolonging medication * Cardiac abnormalities: * Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) \> 450 ms * Inability to measure QT interval on ECG * Personal or family history of long QT syndrome * Implantable pacemaker or implantable cardioverter defibrillator * Resting bradycardia \< 55 beats/min * Presence of serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism, and other active malignancy associated with life expectancy of less than 1 year) * Pregnant or breastfeeding females and male or female patients who refuse to use adequate contraception during the study and for 12 weeks after the last dose of rociletinib * Any contraindication, allergy, or hypersensitivity to rociletinib or excipients
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 11 sites
Compassionate Care Research Group, Inc.
Fountain Valley, United StatesPacific Cancer Care
Monterey, United StatesSutter Cancer Institute
Sacramento, United States