- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Florida
-
Tampa, Florida, Stati Uniti, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
Altri nomi:
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Phase I: Maximum Tolerated Dose (MTD)
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Complete Molecular Response Rate
Lasso di tempo: Up to 36 months
|
Complete molecular response rate (CMR >4.5 log reduction) after the treatment combination.
|
Up to 36 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Kendra Sweet, M.D., H. Lee Moffitt Cancer Center and Research Institute
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MCC-17114
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Nilotinib
-
Novartis PharmaceuticalsTerminatoIpertensione arteriosa polmonareSvizzera, Stati Uniti, Germania, Singapore, Corea, Repubblica di, Canada
-
Niguarda HospitalCompletatoLeucemia, mieloide, fase cronicaItalia
-
Georgetown UniversitySconosciutoMorbo di Parkinson | Malattia Di Parkinson Con DemenzaStati Uniti
-
KeifeRx, LLCWorldwide Clinical Trials; Life Molecular Imaging GmbH; Sun Pharmaceuticals Industries...Non ancora reclutamento
-
Shenzhen Second People's HospitalDongguan People's Hospital; Zhongshan People's Hospital, Guangdong, China; The... e altri collaboratoriReclutamentoLeucemia mieloide cronica, fase cronica | NilotinibCina
-
Andrew J. Wagner, MD, PhDMassachusetts General Hospital; Novartis; Brigham and Women's HospitalAttivo, non reclutanteTumore a cellule giganti tenosinoviale | Sinovite villonodulare pigmentata | Tumore a cellule giganti di tipo diffusoStati Uniti
-
Novartis PharmaceuticalsNon più disponibileSindrome ipereosinofila (HES)
-
Novartis PharmaceuticalsNon più disponibile
-
Novartis PharmaceuticalsCompletato