Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
Collecte de données
Néoplasmes pulmonaires+4
+ Maladies pulmonaires
+ Néoplasmes par site
Étude thérapeutique
Résumé
The purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen.
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.Traitement
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.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Histologically or cytologically confirmed Stage IIIb/IV NSCLC * Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC * Measurable disease * ECOG Performance Status of 0 or 1 * Expected survival ≥12 weeks * Provide written informed consent Exclusion Criteria: * More than 2 prior chemotherapy regimens * Brain metastases (exception: patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month) * Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix * The need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy * A history of severe hypersensitivity reactions to drugs formulated with polysorbate 80 * A history of myocardial infarction within 1 year of study entry, CABG within 6 months of study entry, severe congestive heart failure (ejection fraction \<30%), history of ventricular arrhythmia, or other uncontrolled cardiac arrhythmia * Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol * Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment in order to be enrolled. * Pregnant or lactating women. * Clinically significant laboratory abnormalities, specifically: Total bilirubin ≥institutional upper limit of normal (ULN); Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase \>2.5 x ULN; Hepatitis B surface antigen or antibody to Hepatitis C (anti-HCV antibody); Serum creatinine ≥2.0mg/dL; or Granulocytes \<1500/μL or platelets \<100,000/μL.
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 10 sites
University of Chicago
Chicago, United StatesVan Elslander Cancer Center
Grosse Pointe Woods, United StatesNew York Oncology/Hematology--Albany Regional Cancer Center
Albany, United States