Spots Global Cancer Trial Database for A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
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Trial Identification
Brief Title: A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
Official Title: A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
Study ID: NCT00745550
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Scottsdale, Arizona, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Royal Melbourne Hospital, Melbourne, Victoria, Australia
Royal Adelaide Hospital, Adelaide, , Australia
Contact Details
Name: John Seymour, M.D.
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: PRINCIPAL_INVESTIGATOR
Name: Andrew Roberts, M.D.
Affiliation: Melbourne Health
Role: PRINCIPAL_INVESTIGATOR
Name: Bik To, MD
Affiliation: Royal Adelaide Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Rami Komrokji, MD
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Martha Wadleigh, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Ruben Mesa, MD
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
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