Clinical trial NCT00741234: A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Hematologic Malignancies
Myelodysplastic Syndrome
Keywords: SB939
Myelodysplastic Syndrome
Combination with azacitidine
Solid malignancies
Hematologic malignancies
HDAC inhibitor
Refractory to standard therapy
Lead sponsor: S*BIO
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label, dose escalation study with 3 arms (Arms A, B, and C). 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. Arm C will assess the safety and tolerability of SB939 in combination with standard azacitidine therapy.


Eligibility criteria: Inclusion criteria:

Arms A \& B:

* Patients with solid tumors in Arm A and hematologic malignancies in Arm B that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
* ECOG performance status (PS) 0-2;
* Patients must have adequate non-hematologic organ system function.

Arm C:

* Patients with MDS that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
* Have not been treated with azacitidine and are a candidate for treatment with azacitidine;
* ECOG performance status (PS) 0-2;
* Patients must have adequate non-hematologic organ system function.

Primary outcomes:
measure: 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, either alone (Arms A and B), or in combination with azacitidine therapy in (Arm C).
timeFrame: Throughout the study
Secondary outcomes:
measure: 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
timeFrame: Throughout the study
measure: To determine the dose limiting toxicities of SB939
timeFrame: Throughout the study
measure: To determine the pharmacokinetic profile of SB939
timeFrame: Throughout the study
measure: To assess histone acetylation in PBMC and other biomarkers
timeFrame: Throughout the study
measure: To document anti-tumor activity
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Center
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: University of Wisconsin, Madison
name: George Wilding, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Hospital, Singapore
name: Boon Cher Goh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Center
name: Han Chong Toh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore General Hospital
name: Charles Chuah, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Guillermo Garcia-Manero, MD
role: PRINCIPAL_INVESTIGATOR
References: