A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies

NCT00719836 | Completed Phase 1

• 1 other identifier: SB1518-2007-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief Summary

This 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 advanced myeloid malignancies; 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 chronic idiopathic myelofibrosis (CIMF).

Conditions

Acute Myelogenous Leukemia; Chronic Myelogenous Leukemia; Chronic Myelomonocytic Leukemia; Myelodysplastic Syndromes; Myelofibrosis

Keywords

SB1518; Chronic Idiopathic Myelofibrosis; 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 in subjects with advanced myeloid malignancies

  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 (2)

• Assess the safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies

  Throughout the study

• Assess the pharmacokinetic and 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:

• During the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. This includes the following:
• Subjects with Acute Myelogenous Leukemia (AML)
• Subjects with Chronic Myelogenous Leukemia (CML) in accelerated phase
• Subjects with Chronic Myelogenous Leukemia (CML) in blast crisis
• Subjects with high-risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
• Subjects with Advanced Myelofibrosis (MF)
• In Phase 2, subjects with CIMF (as well as post ET/PV MF)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
• Able to understand and willing to sign the informed consent form

You may not qualify if:

• Subjects with Chronic Myelogenous Leukemia (CML) in chronic phase;
• 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;
• Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study;
• Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy);
• Known active hepatitis A, B, or C;
• Women who are pregnant or lactating.

Sponsors & Collaborators

• S*BIO: lead

Study Sites (3)

The University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Verstovsek S, Odenike O, Singer JW, Granston T, Al-Fayoumi S, Deeg HJ. Phase 1/2 study of pacritinib, a next generation JAK2/FLT3 inhibitor, in myelofibrosis or other myeloid malignancies. J Hematol Oncol. 2016 Dec 8;9(1):137. doi: 10.1186/s13045-016-0367-x.

  PMID: 27931243 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myelomonocytic, Chronic; Myelodysplastic Syndromes; Primary Myelofibrosis

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)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myelodysplastic-Myeloproliferative Diseases

Study Officials

• Srdan Verstovsek, M.D, Ph.D

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• H. Joachim Deeg, M.D

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

• Olatoyosi M. Odenike, M.D.

  The University of Chicago Hospitals

  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: July 20, 2008
• First Posted: July 22, 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)