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

NCT ID: NCT00745550

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2012-01-31

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.

Conditions

Myelofibrosis; Myeloproliferative Disorders; Polycythemia Vera; Essential Thrombocythemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

SB1518

SB1518 taken orally daily for 28 consecutive days in a 28-day cycle

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S*BIO

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Seymour, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peter MacCallum Cancer Centre, Australia

Andrew Roberts, M.D.

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Bik To, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Adelaide Hospital

Rami Komrokji, MD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Martha Wadleigh, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Ruben Mesa, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

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

Countries

United States; Australia

References

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.

Reference Type: DERIVED

PMID: 25762180 (View on PubMed)

Other Identifiers

SB1518-2008-003

Identifier Type: -

Identifier Source: org_study_id