A Phase I Study of SB1518 for the Treatment of Advanced Myeloid Malignancies - Full Text View

Sponsor:	S*BIO
Information provided by:	S*BIO
ClinicalTrials.gov Identifier:	NCT00719836

Purpose

This is a phase I dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced myeloid malignancies.

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

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase I Study of SB1518 for the Treatment of Advanced Myeloid Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Spleen Diseases

U.S. FDA Resources

Further study details as provided by S*BIO:

Primary Outcome Measures:

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 ]

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 ]

Estimated Enrollment:	30
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

The starting dose of SB1518 will be 100mg 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:

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)
Age ≥ 18 years old
Eastern Co-operative 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 hear 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	Recruiting
Chicago, Illinois, United States, 60637
Contact: Peggy Green, RN 773-834-2119 mgreen@medicine.bsd.uchicago.edu
Principal Investigator: Olatoyosi M. Odenike, M.D.
United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Betsy Williams, RN 713-792-1993 betsyw@mdanderson.org
Contact: Carol Bibens, RN 713-794-4460 cbibins@mdanderson.org
Principal Investigator: Srdan Verstovsek, M.D, Ph.D
United States, Washington
Fred Hutchinson Cancer Center	Recruiting
Seattle, Washington, United States, 98109
Contact: Franchesca Nguyen Ttnguye3@fhcrc.org
Principal Investigator: H. Joachim Deeg, M.D

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 ( Joy Zhu, M.D., Ph.D./Senior Vice President, Global Clinical Development )
Study ID Numbers:	SB1518-2007-001
Study First Received:	July 20, 2008
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00719836 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Myelofibrosis
Disease
Neoplasms by Histologic Type
Precancerous Conditions
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myeloid Metaplasia

Leukemia, Myelomonocytic, Acute
Lymphatic Diseases
Leukemia
Neoplasms
Preleukemia
Pathologic Processes
Syndrome
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Splenic Diseases

ClinicalTrials.gov processed this record on February 08, 2010