Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01243944Tipo: INTERVENTIONALInicio: 27 de oct de 2010Fin estimado: 9 de feb de 2018

Traducción no disponible, mostrando original

Resumen

This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants diagnosed with PV for at least 24 weeks prior to screening according to the 2008 World Health Organization criteria
Participants resistant to or intolerant of hydroxyurea
Participants with a phlebotomy requirement
Participants with splenomegaly (palpable or non-palpable) and a spleen volume, as measured by MRI (or CT in applicable participants ), of greater than or equal to 450 cubic centimeters
Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Criterios de exclusión

Women who are pregnant or nursing
Participants with inadequate liver or renal function
Participants with significant bacterial, fungal, parasitic, or viral infection requiring treatment
Participants with an active malignancy within the past 5 years, excluding specific skin cancers
Participants with known active hepatitis or HIV positivity
Participants who have previously received treatment with a JAK inhibitor
Participants being treated with any investigational agent

Intervenciones

drug

ruxolitinib tablets

Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy

other

Best Available Therapy (BAT)

Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

Ubicaciones

Buenos Aires, Argentina

Patrocinadores

PrincipalIncyte Corporation

ColaboradorNovartis Pharmaceuticals

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