A Phase I Dose Escalation Study of Oral SB939 - Full Text View

Sponsor:	S*BIO
Information provided by:	S*BIO
ClinicalTrials.gov Identifier:	NCT00741234

Purpose

This is an open label, dose escalation study with 2 arms (Arm A and Arm B). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in cohorts of patients with advanced hematologic malignancies.

Condition	Intervention	Phase
Solid Tumors Hematologic Malignancies	Drug: SB939	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	A Phase I Dose Escalation Study of Oral SB939 When Administered Thrice Weekly (Every Other Day) for 3 Weeks in a 4-week Cycle in Patients With Advanced Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by S*BIO:

Primary Outcome Measures:

To assess the safety and tolerability of SB939, administered orally every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks, in patients with advanced malignancies. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To establish the maximum tolerated dose and a recommended phase II dose of SB939 as a single agent when administered every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
To determine the dose limiting toxicities of SB939 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
To determine the pharmacokinetic profile of SB939 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
To assess histone acetylation in PBMC and other biomarkers [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
To document anti-tumor activity [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Advanced solid tumors	Drug: SB939 The starting dose of SB939 will be 10 mg every other day three times a week in a 4-week cycle. Each 4-week cycle consists of three weeks treatment of SB939 followed by a one week rest period.
B: Experimental Advanced hematologic malignancies	Drug: SB939 The starting dose of SB939 will be 10 mg every other day three times a week in a 4-week cycle. Each 4-week cycle consists of three weeks treatment of SB939 followed by a one week rest period.

Eligibility

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

Criteria

Inclusion Criteria:

Pathologically-confirmed, locally advanced or metastatic solid tumors that are refractory to standard therapy or for which conventional therapy is not reliably effective (Arm A only)
Evidence of unidimensionally measurable disease by radiographic techniques (CT or MRI) (Arm A only)
Patients with hematological malignancies (refractory or relapsing leukemia, high-risk myelodysplastic syndrome (MDS), multiple myeloma (MM), indolent or aggressive non-Hodgkin's lymphoma (NHL), or Hodgkin's disease). Patients must have failed, relapsed, or not be eligible for standard effective therapy or a peripheral blood stem cell transplant (Arm B only)
ECOG performance status (PS) 0-2
Life expectancy ≥3 months
No pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum) within the 14 days prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy
No clinically significant co-morbidities, such as cardiac or pulmonary disease, active CNS disease, and active infection
No known HIV infection
Ability to cooperate with treatment and follow-up
Ability to understand and willingness to sign informed consent prior to initiation of any study procedures

Exclusion Criteria:

Failed to recover from the reversible effects of previous chemotherapy, radiotherapy, or immunotherapy prior to enrollment
Any of the following in the past 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically symptomatic and uncontrolled cardiovascular disease, ongoing cardiac dysrhythmias of NCI CTC grade ≥2, atrial fibrillation of any grade. Prolongation of the QTc interval to >450 msec for males or >470 msec for females at baseline
Concomitant treatment with HDAC inhibitors such as valproic acid is not permitted
Known brain metastasis or leptomeningeal disease
Manifestation of malabsorption due to prior surgery, gastrointestinal (GI) disease, or for an unknown reason. Patients may have had major GI surgery but must not have residual symptomatic manifestations of malabsorption
Any acute or chronic medical or psychiatric condition, or a laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741234

Locations

United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Moneida Holmes 713-792-0850 moholmes@mdanderson.org
Principal Investigator: Guillermo Garcia-Manero, MD
United States, Wisconsin
University of Wisconsin-Madison	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jeffrey D. Bozeman 608-263-6222 jb10@medicine.wisc.edu
Contact: Jennifer Heideman
Principal Investigator: George Wilding, M.D.
Singapore
National University Hospital	Completed
Singapore, Singapore, 119074
National Cancer Center	Completed
Singapore, Singapore, 160610
Singapore General Hospital	Recruiting
Singapore, Singapore, 169608
Contact: Pei Wen Eng (65) 6321 4627 eng.pei.woon@sgh.com.sg
Principal Investigator: Charles Chuah, M.D.

Sponsors and Collaborators

S*BIO

Investigators

Principal Investigator:	George Wilding, M.D.	University of Wisconsin, Madison
Principal Investigator:	Boon Cher Goh, M.D.	National University Hospital, Singapore
Principal Investigator:	Han Chong Toh, M.D.	National Cancer Center
Principal Investigator:	Charles Chuah, M.D.	Singapore General Hospital
Principal Investigator:	Guillermo Garcia-Manero, MD	M.D. Anderson Cancer Center

More Information

No publications provided

Responsible Party:	S*BIO PTE LTD ( Joy Zhu, M.D., Ph.D., Senior Vice President, Global Clinical Development )
Study ID Numbers:	SB939-2006-001
Study First Received:	August 22, 2008
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00741234 History of Changes
Health Authority:	United States: Food and Drug Administration; Singapore: Health Sciences Authority

Keywords provided by S*BIO:

SB939
Solid malignancies
Hematologic malignancies
HDAC inhibitor
Refractory to standard therapy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Hematologic Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on February 08, 2010