- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01738438
Cabozantinib for Metastatic Triple Negative BrCa
A Phase II Study of XL184 (Cabozantinib) for Metastatic Triple-Negative Breast Cancer
Aperçu de l'étude
Description détaillée
OBJECTIVES:
Primary
* To evaluate the activity of cabozantinib, as defined by objective response rate in patients with triple-negative metastatic breast cancer
Secondary
- To evaluate progression free survival
- To evaluate c-Met and phospho c-Met expression in archival tumor tissue
- To evaluate the incidence of c-Met amplified circulating tumor cells at baseline
- To evaluate potential plasma biomarkers of cabozantinib
DESIGN:
This study uses a two-stage design enrolling 35 patients to evaluate efficacy of cabozantinib based on overall response defined as complete or partial response per RECIST1.1 criteria. The null and alternative overall response rates were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=13 patients) achieve PR or better then accrual proceeds to stage two (n=22 patients).
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, États-Unis, 02214
- Massachusetts General Hospital
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Boston, Massachusetts, États-Unis, 02130
- Dana-Farber Cancer Institute at Faulkner Hospital
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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 invasive breast cancer with stage IV disease
- Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative
- May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer. Must be off treatment for at least 21 days prior to enrollment
- Must have discontinued all biologic therapy at least 14 days before enrollment
- May have received prior radiation therapy in the early stage or metastatic setting, but must have completed treatment at least 14 days prior to enrollment
- Must agree to use medically acceptable methods of contraception
- Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue
- Able to swallow tablets
Exclusion Criteria:
- Pregnant or breastfeeding
- Received another investigational agent within 14 days prior to enrollment
- Received prior c-Met inhibitor
- Known brain metastases that are untreated, symptomatic or require therapy to control symptoms
- Psychiatric illness or social situation that could limit ability to comply with study requirements
- Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet agents
- Diagnosis of another malignancy requiring systemic treatment within the last two years (except non-melanoma skin cancer or in-situ carcinoma of the cervix)
- Known to be positive for HIV
- Active infection requiring IV antibiotics at Day 1 of cycle 1
- Uncontrolled, significant intercurrent illness
- Requires chronic concomitant treatment of a strong CYP3A4 inducer
- tumor in contact with, invading or encasing major blood vessels
- Have experienced clinically significant gastrointestinal bleeding within 6 months, hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs indicative of pulmonary hemorrhage within 3 months of enrollment
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: Cabozantinib
Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles.
Treatment continued in the absence of disease progression or unacceptable toxicity.
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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Objective Response Rate
Délai: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).
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The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria.
For target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Confirmatory scans were required 3 weeks following initial documentation.
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Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression Free Survival
Délai: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).
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Progression-free survival (PFS) estimated using Kaplan-Meier methods was defined as the time from registration to documented disease progression (PD) or death.
Based on RECIST1.1, radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Patients who were event-free were censored at the date of their last disease evaluation.
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Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sara Tolaney, MD, MPH, Dana-Farber Cancer Institute
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12-431
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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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