Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
15 janvier 2015 mis à jour par: Pfizer
A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
34
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Arizona
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Scottsdale, Arizona, États-Unis, 85258
- Premiere Oncology of Arizona
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Scottsdale, Arizona, États-Unis, 85255
- Scottsdale Medical Imaging, Ltd.
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California
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Santa Monica,, California, États-Unis, 90404
- Premiere Oncology, A Medical Corporation
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19111
- Fox Chase Cancer Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy.
- Adequate coagulation, liver, and renal function.
- Candidate for DCE-MRI evaluations.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Exclusion Criteria:
- Evidence of significant bleeding problems.
- History of certain gastrointestinal problems including fistula and abscess.
- Chronic, uncontrolled hypertension.
- Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- 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: 1
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Weekly, intravenous dose
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Délai: Baseline (Day 0) up to 30 days after last dose of study medication
|
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Relatedness to CVX-060 was assessed by the investigator (Yes/No).
Participants with multiple occurrences of an AE within a category were counted once within the category.
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Baseline (Day 0) up to 30 days after last dose of study medication
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Maximum Observed Serum Concentration (Cmax)
Délai: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Serum Decay Half-Life (t1/2)
Délai: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
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Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]
Délai: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
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Apparent Volume of Distribution (Vss)
Délai: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Apparent Clearance (CL)
Délai: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).
Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Time to Reach Maximum Observed Serum Concentration (Tmax)
Délai: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
|
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Recommended Phase 2 Dose (RP2D): Stage 1
Délai: Baseline (Day 0) up to 42 days after the last dose of study medication
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RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings.
DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.
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Baseline (Day 0) up to 42 days after the last dose of study medication
|
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Number of Participants With Anti-CVX-060 Antibodies
Délai: Baseline (Day 0) up to 42 days after last dose
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Baseline (Day 0) up to 42 days after last dose
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Number of Samples From Participants With Anti-CVX-060 Antibodies
Délai: Baseline (Day 0) up to 42 days after last dose
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Baseline (Day 0) up to 42 days after last dose
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Number of Participants With Best Overall Response (BOR)
Délai: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
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BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response (CR): disappearance of all lesions.
Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions.
PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions.
Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start.
CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response.
SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks.
Participants with >=3 treatments cycles were reported.
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Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2008
Achèvement primaire (Réel)
1 avril 2011
Achèvement de l'étude (Réel)
1 avril 2011
Dates d'inscription aux études
Première soumission
9 avril 2009
Première soumission répondant aux critères de contrôle qualité
9 avril 2009
Première publication (Estimation)
10 avril 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
26 janvier 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 janvier 2015
Dernière vérification
1 janvier 2015
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B1131002
- CVX-060-101 (Autre identifiant: Alias Study Number)
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 .