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

NCT ID: NCT00719836

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2012-01-31

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

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

• 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

Exclusion Criteria

• 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.

• 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

Srdan Verstovsek, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

H. Joachim Deeg, M.D

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Olatoyosi M. Odenike, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Chicago Hospitals

Locations

The University of Chicago Hospitals

Chicago, Illinois, United States

MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27931243 (View on PubMed)

Other Identifiers

SB1518-2007-001

Identifier Type: -

Identifier Source: org_study_id