A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine

Sponsor

S*BIO (Industry)

Overall Status

Completed

CT.gov ID

NCT00741234

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors Hematologic Malignancies Myelodysplastic Syndrome	Drug: SB939 Drug: Azacitidine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Advanced solid tumors	Drug: SB939 SB939 taken orally in a 4-week cycle.
Experimental: B Advanced hematologic malignancies	Drug: SB939 SB939 taken orally in a 4-week cycle.
Experimental: C Myelodysplastic Syndrome	Drug: SB939 SB939 taken orally in a 4-week cycle. Drug: Azacitidine Azacitidine taken orally with SB939 in a 4-week cycle Other Names: Vidaza

Arm

Intervention/Treatment

Experimental: A

Advanced solid tumors

Drug: SB939

SB939 taken orally in a 4-week cycle.

Experimental: B

Advanced hematologic malignancies

Drug: SB939

SB939 taken orally in a 4-week cycle.

Experimental: C

Myelodysplastic Syndrome

Drug: SB939

SB939 taken orally in a 4-week cycle.

Drug: Azacitidine

Azacitidine taken orally with SB939 in a 4-week cycle

Other Names:

Vidaza

Outcome Measures

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, either alone (Arms A and B), or in combination with azacitidine therapy in (Arm C). [Throughout the study]

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 [Throughout the study]
To determine the dose limiting toxicities of SB939 [Throughout the study]
To determine the pharmacokinetic profile of SB939 [Throughout the study]
To assess histone acetylation in PBMC and other biomarkers [Throughout the study]
To document anti-tumor activity [Throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MD Anderson Cancer Center	Houston	Texas	United States	77030
2	University of Wisconsin-Madison	Madison	Wisconsin	United States	53792
3	National University Hospital	Singapore		Singapore	119074
4	National Cancer Center	Singapore		Singapore	160610
5	Singapore General Hospital	Singapore		Singapore	169608

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