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

Sponsor

S*BIO (Industry)

Overall Status

Completed

CT.gov ID

NCT00719836

Collaborator

(none)

Enrollment

Locations

Duration (Months)

25.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia Chronic Myelogenous Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes Myelofibrosis	Drug: SB1518	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Chicago Hospitals	Chicago	Illinois	United States	60637
2	MD Anderson Cancer Center	Houston	Texas	United States	77030
3	Fred Hutchinson Cancer Center	Seattle	Washington	United States	98109

Sponsors and Collaborators

S*BIO

Investigators

Principal Investigator: 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