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

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719836
• Other study ID #: SB1518-2007-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 20, 2008
• Last updated: April 19, 2012
• Start date: August 2008
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: S*BIO
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago Hospitals	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	Fred Hutchinson Cancer Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
S*BIO

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose.		Throughout the study	Yes
Secondary	Assess the safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies		Throughout the study	Yes
Secondary	Assess the pharmacokinetic and pharmacodynamic profile of SB1518		Throughout the study	No