A Phase I Study of PT-523 in Patients With Solid Tumors
Collecte de données
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mars 2004
Date à laquelle le premier participant a commencé l'étude.The primary objectives of this study are 1) to evaluate the safety of a short intravenous infusion of PT-523 when administered on days 1, 8, and 15 of a 28-day cycle to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist; and 2) to establish the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of PT-523. The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523.
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.40 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.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.Critères
Inclusion Criteria: * Presence of metastatic or inoperable malignancy, other than leukemia or a primary central nervous system (CNS) tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies . * Age greater than or equal to 18 years. * Life expectancy greater than or equal to 2 months. * ECOG performance status 0 - 2. * Adequate organ function and bone marrow reserve. * Use of appropriate contraceptive method. * Sign patient informed consent. Exclusion Criteria: * Active brain metastases. * Presence of third-space fluid collections (pleural effusion, ascites). * Major surgery within 3 weeks prior to dosing. * Prior chemotherapy or radiation therapy within 3 weeks prior to dosing (6 weeks for nitrosoureas or mitomycin-C). Prior antifolate therapy is permitted, as long as it has not been administered within 3 weeks prior to dosing with PT-523. * Prior bone marrow transplantation. * Presence of uncontrolled serious medical or psychiatric illness. * Patients requiring radiation therapy. There are no limitations on the extent or type of prior therapy received by the patient other than the time intervals indicated above, as long as the patient has demonstrated complete recovery from any adverse effects, and fulfills all relevant inclusion criteria.
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 3 sites
Dana-Farber Cancer Institute
Boston, United StatesBeth Isreal Deaconess Medical Center
Boston, United States