Terminé

A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

Collecte de données

Qui peut participer

Maladies génito-urinaires+7

+ Maladies Génitales

+ Maladies génitales masculines

À partir de 19 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel
Voir le détail du protocole

Résumé

Sponsor principalGenzyme, a Sanofi Company
Dernière mise à jour : 13 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this study that is expected to last 24 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The primary objective of this study is to determine the PSA response rate. The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651.

Titre officielA Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel 
NCT00082134
Sponsor principalGenzyme, a Sanofi Company
Dernière mise à jour : 13 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

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.
Détails du design

40 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.


Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Homme

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 19 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

Maladies génito-urinairesMaladies GénitalesMaladies génitales masculinesNéoplasmes génitaux, mâlesNéoplasmes par siteNéoplasmesMaladies prostatiquesTumeurs de la ProstateNéoplasmes urogénitauxMaladies urogénitales masculines

Critères

Inclusion Criteria: * Patient has hormone-refractory prostate cancer (HRPC) as evidenced by PSA progression or progression of measurable disease. * Patient has greater than 25% increase in 2 consecutive tests in which the first increase in PSA should occur a minimum of 1 week apart. * Patients on androgen deprivation treatment and will continue on androgen deprivation treatment during study participation except for patients who are post orchiectomy. * Patient has evidence of metastatic disease by positive bone scan or evidence of progressive metastatic disease by CT scan. * Patient has been treated with at least 1 prior hormone therapy or is post orchiectomy. * Patient has been previously treated at a minimum for an 8-week treatment period on a docetaxel-based regimen for metastatic HRPC. * Patient has PSA at least 5 ng/mL or greater. * Patient has testosterone less than 50 ng/dL. * Patient ECOG performance status of 0 or 1. * Patient has life expectancy of greater than 8 weeks. * Patient meets lab values: A. Absolute neutrophil count at least 1,500/mm\^3 or greater; B.Platelet count at least 100,000/mm\^3 or greater; C. Serum creatinine at least 1.5 mg/dL or less or creatinine clearance at least 60 mL/min or greater; D. Bilirubin less than 2.0 mg/dL. E. AST and ALT less or equal to 2.5 times upper limit of normal * Any chemotherapy, major surgery, or irradiation must be completed at least 4 weeks prior to study drug. * Patient recovered from clinically significant toxicities from prior treatment. Exclusion Criteria: * Prior treatment with 2 or more prior chemotherapy regimens. * Concurrent treatment with an estrogen-containing agent including diethylstilbestrol (DES). * Prior flutamide (Eulexin) within past 4 weeks, prior bicalutamide (Casodex) within past 6 weeks, or prior nilutamide (Nilandron) within past 6 weeks. * Prior strontium or samarium or other radioisotope therapy. * Prior radiation therapy to greater than 25% of the bone marrow (e.g., no whole pelvic irradiation is allowed). * Uncontrolled congestive heart failure or angina, patients with a history of myocardial infarction within 2 months of enrollment. * Patients with uncontrolled hypertension. * Pre-existing cardiac, pulmonary, neurologic or other disease that would preclude study participation. * Documented untreated central nervous system (CNS) metastases. However, patients with treated CNS metastases that have been stable are eligible. * Any significant concurrent disease or illness, or psychiatric disorders or alcohol or chemical abuse that would preclude study participation. * Active secondary malignancy except non-melanoma skin cancers. * Known, active infection, or known HIV positive or presence of an AIDS related illness.

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 12 sites

Suspendu

Arizona Clinical Research Center

Tucson, United StatesVoir le site
Suspendu

Kansas City Cancer Centers

Lenexa, United States
Suspendu

Kansas City Cancer Centers

Overland Park, United States
Suspendu

Kansas City Cancer Centers- Central

Kansas City, United States
Terminé12 Centres d'Étude