A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies - Full Text View

Sponsor:	S*BIO
Information provided by (Responsible Party):	S*BIO
ClinicalTrials.gov Identifier:	NCT00719836

Purpose

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	Intervention	Phase
Acute Myelogenous Leukemia Chronic Myelogenous Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes Myelofibrosis	Drug: SB1518	Phase I Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies

Resource links provided by NLM:

Genetics Home Reference related topics: primary myelofibrosis

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Chronic Myeloid Leukemia Leukemia Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by S*BIO:

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 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Assess the pharmacokinetic and pharmacodynamic profile of SB1518 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment:	76
Study Start Date:	August 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719836

Locations

United States, Illinois
The University of Chicago Hospitals
Chicago, Illinois, United States, 60637
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
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

More Information

No publications provided

Responsible Party:	S*BIO
ClinicalTrials.gov Identifier:	NCT00719836 History of Changes
Other Study ID Numbers:	SB1518-2007-001
Study First Received:	July 20, 2008
Last Updated:	September 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by S*BIO:

SB1518
Chronic Idiopathic Myelofibrosis
JAK2 Inhibitor

Additional relevant MeSH terms:

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

Leukemia, Myelomonocytic, Acute
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on February 09, 2012