- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01702064
Ruxolitinib in Combination With Nilotinib in Chronic Myeloid Leukemia (CML) Patients
A Phase I Study of Ruxolitinib in Combination With Nilotinib in CML Patients With Evidence of Molecular Disease
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
Florida
-
Tampa, Florida, États-Unis, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Must have chronic phase chronic myeloid leukemia (CML). They must also be under treatment with nilotinib as either first, second, or third-line therapy.
- Must have a complete cytogenetic response (CCyR) OR must have been on nilotinib for a minimum of 6 months.
- Must not have undergone treatment for any other form of cancer (aside from non-melanoma skin cancer) in the past 5 years.
- 18 years of age or older and must be able to speak and read English or Spanish.
- Able to provide informed consent.
- Prior therapy with a tyrosine kinase inhibitor (TKI) other than nilotinib is allowable, however, nilotinib must be the current therapy. All participants must be under the care of a Moffitt Cancer Center physician, and enrollment is expected to be complete within 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%.
- Must have normal organ and marrow function as defined in study protocol.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Ruxolitinib and nilotinib administration. Women of child-bearing age will be required to have a negative pregnancy test within 14 days of enrolling in this study.
- Ability to understand and the willingness to sign a written informed consent document
- B-HCG will be performed on all women of child-bearing potential as screening prior to enrollment on this trial. STAT3 levels in the bone marrow will also be measured prior to enrollment.
Exclusion Criteria:
- Patients who are in accelerated phase or blast phase CML.
- May not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib or other agents used in the study.
- Known history of a prolonged QT interval (QTc >480).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study. Women who are breast feeding their infants should discontinue this practice if the mother is treated with ruxolitinib.
- Currently receiving any drugs considered to be strong CYP3A4 inducers or inhibitors which cannot be discontinued or changed to an alternative drug prior to enrolling on the trial.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study.
- Patients receiving nilotinib 200 mg by mouth, twice a day (PO BID) or a lower dose are not eligible.
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 |
---|---|
Expérimental: Nilotinib with Ruxolitinib
The starting dose of ruxolitinib will be 5mg by mouth (PO) twice a day (BID) and will increase by 5 mg increments in each cohort, to a maximum dose of 15 mg PO BID. Nilotinib will be given at a dose ranging from 300 mg PO BID to 400 mg PO BID, depending on the participant's dose prior to enrollment on the trial. Dose Level 1: Ruxolitinib 5 mg twice a day (BID); Nilotinib 300 mg or 400 mg BID. Dose Level 2: Ruxolitinib 10 mg BID; Nilotinib 300 mg or 400 mg BID. Dose Level 3: Ruxolitinib 15 mg BID; Nilotinib 300 mg or 400 mg BID. |
Participants will remain on the same dose of nilotinib they have been receiving prior to enrollment on the trial. This will range from 300 mg PO BID to 400 mg PO BID. Dose modifications will not occur, as the purpose of this study is to determine the maximum tolerated dose of ruxolitinib, based on the number of dose.
Autres noms:
Dose escalation will follow a 3+3 study design.
Dose modifications will not occur, as the purpose of this study is to determine the maximum tolerated dose, based on the number of dose limiting toxicities seen at a specific dose.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Phase I: Maximum Tolerated Dose (MTD)
Délai: Average of 6 months
|
Maximum tolerated dose (MTD) of ruxolitinib with nilotinib. Dose escalation will follow a 3+3 study design. If 2 or more participants within a cohort experience a dose limiting toxicity (DLT), then the MTD will have been exceeded and the preceding dose level will be evaluated as the MTD. A minimum of 6 participants must be evaluated at the dose level in order for it to be declared as the MTD. Dose limiting toxicity is defined as:
|
Average of 6 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Complete Molecular Response Rate
Délai: Up to 36 months
|
Complete molecular response rate (CMR >4.5 log reduction) after the treatment combination.
|
Up to 36 months
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Kendra Sweet, M.D., H. Lee Moffitt Cancer Center and Research Institute
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
- MCC-17114
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 .
Essais cliniques sur Leucémie myéloïde chronique en phase chronique
-
PfizerComplétéLeucémie, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) PositifFrance, États-Unis, Canada, Espagne, Tchéquie, Singapour, Thaïlande, Danemark, Norvège, Corée, République de, Finlande, Hongrie, Suède, Pays-Bas, Italie, Allemagne, Ukraine, Afrique du Sud, Taïwan, Australie, Belgique, Israël, Mexique, Pologn... et plus
Essais cliniques sur Nilotinib
-
Niguarda HospitalComplétéLeucémie, myéloïde, phase chroniqueItalie
-
Novartis PharmaceuticalsRésiliéHypertension artérielle pulmonaireSuisse, États-Unis, Allemagne, Singapour, Corée, République de, Canada
-
Georgetown UniversityInconnueMaladie de Parkinson | Maladie de Parkinson avec démenceÉtats-Unis
-
KeifeRx, LLCWorldwide Clinical Trials; Life Molecular Imaging GmbH; Sun Pharmaceuticals...Pas encore de recrutement
-
Shenzhen Second People's HospitalDongguan People's Hospital; Zhongshan People's Hospital, Guangdong, China; The... et autres collaborateursRecrutementLeucémie myéloïde chronique, phase chronique | NilotinibChine
-
Andrew J. Wagner, MD, PhDMassachusetts General Hospital; Novartis; Brigham and Women's HospitalActif, ne recrute pasTumeur à cellules géantes ténosynoviales | Synovite villonodulaire pigmentée | Tumeur à cellules géantes de type diffusÉtats-Unis
-
Novartis PharmaceuticalsPlus disponibleSyndrome hyperéosinophile (SHE)
-
Novartis PharmaceuticalsPlus disponible
-
Novartis PharmaceuticalsComplété
-
Jill M KolesarNational Cancer Institute (NCI); NovartisRecrutementMélanome métastatique | Mutation du gène BRAFÉtats-Unis