- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00022529
BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
Phase I Study of Intravenous BMS-214662 FTI (NSC# 710086) and Herceptin (NSC# 688097) Weekly in Patients With Advanced Malignancies
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of BMS-214662 when combined with trastuzumab (Herceptin) in patients with advanced solid tumors.
II. Determine the dose-limiting toxic effects of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics of this regimen in these patients. Ii. Determine, in a preliminary manner, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of BMS-214662.
Patients receive BMS-214662 IV over 1 hour on days 2, 8, 15, and 22 and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with BMS-214662 and trastuzumab at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 3-28 patients will be accrued for this study.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19111-2497
- Fox Chase Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective therapy exists
- Overexpressing HER-2-neu (2+ or 3+) by immunohistochemistry or fluorescent in situ hybridization
- Clinically or radiologically evaluable disease
No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease
- At least 8 weeks since prior therapy for prior brain parenchymal disease and asymptomatic off corticosteroids
- Performance status - ECOG 0-2
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.8 mg/dL
- ALT and AST no greater than 1.5 times upper limit of normal (ULN)
- Creatinine no greater than 1.5 times ULN
- No uncontrolled or significant cardiovascular disease
- No myocardial infarction within the past 6 months
- No prior clinically significant atrial or ventricular arrhythmias
- No prior second or third degree heart block
- No ischemic heart disease requiring medication
- No congestive heart failure
- Corrected QT interval no greater than 450 milliseconds by electrocardiogram
- Ejection fraction at least lower limit of normal by MUGA scan
- No uncontrolled or significant pulmonary disease
- No active unresolved infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
- At least 4 weeks since prior immunotherapy, including trastuzumab (Herceptin), and recovered
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No anthracyclines for at least 22 weeks after completion of study therapy
- No other concurrent chemotherapy
- Concurrent hormone replacement therapy allowed
- No other concurrent hormonal therapy
- At least 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to more than 25% of the bone marrow-containing skeleton
- No concurrent radiotherapy
- At least 4 weeks since prior investigational agents and recovered
- At least 7 days since prior known substrates of cytochrome P450-3A4 (CYP3A4)
- At least 7 days since prior parenteral antibiotics
- No concurrent substrates of CYP3A4
- No concurrent parenteral antibiotics
- No other concurrent experimental medications
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Treatment (BMS-214662, trastuzumab)
Patients receive BMS-214662 IV over 1 hour on days 2, 8, 15, and 22 and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
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Études corrélatives
Autres noms:
Étant donné IV
Autres noms:
Étant donné IV
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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MTD defined as the highest dose level at which =< 1/6 subjects experience a study related dose-limiting toxicity (DLT) as assessed by CTC version 2.0
Délai: 28 days
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28 days
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mary Cianfrocca, Fox Chase Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NCI-2012-02396
- FCCC-01013
- CDR0000068828 (Identificateur de registre: PDQ (Physician Data Query))
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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