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A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis

19. april 2012 opdateret af: S*BIO

The study consists of two phases: The first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis (CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase 2 study to define the efficacy and safety profile of single agent SB1518 at the recommended dose in subjects with CIMF.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: SB1518

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2
Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Australien
- - Adelaide, Australien, 5000
    - Royal Adelaide Hospital
- Victoria
  - Melbourne, Victoria, Australien, 3050
    - Royal Melbourne Hospital
  - Melbourne, Victoria, Australien, 3002
    - Peter MacCallum Cancer Centre
Forenede Stater
- Arizona
  - Scottsdale, Arizona, Forenede Stater, 85259
    - Mayo Clinic
- Florida
  - Tampa, Florida, Forenede Stater, 33612
    - H. Lee Moffitt Cancer Center & Research Institute
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02115
    - Dana-Farber Cancer Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Subjects with CIMF (including post ET/PV MF) requiring therapy, including:
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Men of reproductive potential who can agree to practice effective contraception during the entire study period and for one month after the last study treatment
Women of child-bearing potential who have a negative pregnancy test within 14 days prior to the first dose of study drug and can agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists
Subjects who are able to understand and willing to sign the informed consent form

Exclusion Criteria

Subjects with uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study unless the antibiotic is a CYP3A4 inducer/inhibitor
Subjects known to be HIV-positive
Subjects with known active hepatitis A, B, or C, or latent hepatitis B
Women who are pregnant or lactating
Subjects with prior radiation therapy to more than 20% of the hematopoietic marrow (prior radiation to spleen is allowed)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: N/A
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily Tidsramme: Throughout the study	Throughout the study
Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose Tidsramme: Throughout the study	Throughout the study

Sekundære resultatmål

Resultatmål	Tidsramme
Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF Tidsramme: Throughout the study	Throughout the study
Assess the pharmacokinetic profile of SB1518 Tidsramme: Throughout the study	Throughout the study
Assess the pharmacodynamic profile of SB1518 Tidsramme: Throughout the study	Throughout the study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

S*BIO

Efterforskere

Ledende efterforsker: John Seymour, M.D., Peter MacCallum Cancer Centre, Australia
Ledende efterforsker: Andrew Roberts, M.D., Melbourne Health
Ledende efterforsker: Bik To, MD, Royal Adelaide Hospital
Ledende efterforsker: Ruben Mesa, MD, Mayo Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Komrokji RS, Seymour JF, Roberts AW, Wadleigh M, To LB, Scherber R, Turba E, Dorr A, Zhu J, Wang L, Granston T, Campbell MS, Mesa RA. Results of a phase 2 study of pacritinib (SB1518), a JAK2/JAK2(V617F) inhibitor, in patients with myelofibrosis. Blood. 2015 Apr 23;125(17):2649-55. doi: 10.1182/blood-2013-02-484832. Epub 2015 Mar 11.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2008

Primær færdiggørelse (Faktiske)

1. januar 2012

Studieafslutning (Faktiske)