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

NCT00745550 | Completed Phase 1

• 1 other identifier: SB1518-2008-003
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 6

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

Keywords

SB1518; Chronic Idiopathic Myelofibrosis; Myeloproliferative disorders; Polycythemia Vera; Essential Thrombocythemia; JAK2 inhibitor

Outcome Measures

Primary Outcomes (2)

• Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily

  Throughout the study

• Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose

  Throughout the study

Secondary Outcomes (3)

• Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF

  Throughout the study

• Assess the pharmacokinetic profile of SB1518

  Throughout the study

• Assess the pharmacodynamic profile of SB1518

  Throughout the study

Interventions

SB1518 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• S*BIO: lead

Study Sites (6)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3002, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Related Publications (1)

• 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.

  PMID: 25762180 DERIVED

MeSH Terms

Conditions

Primary Myelofibrosis; Myeloproliferative Disorders; Polycythemia Vera; Thrombocythemia, Essential

Interventions

11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders

Study Officials

• John Seymour, M.D.

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

• Andrew Roberts, M.D.

  Melbourne Health

  PRINCIPAL INVESTIGATOR

• Bik To, MD

  Royal Adelaide Hospital

  PRINCIPAL INVESTIGATOR

• Rami Komrokji, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

• Martha Wadleigh, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Ruben Mesa, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

US (3); AU (3)