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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Advanced solid tumors |
|
| B | Experimental | Advanced hematologic malignancies |
|
| C | Experimental | Myelodysplastic Syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB939 | Drug | SB939 taken orally in a 4-week cycle. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Arms A & B:
Arm C:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| University of Wisconsin-Madison |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Azacitidine |
| Drug |
Azacitidine taken orally with SB939 in a 4-week cycle |
|
|
| 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 |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| National University Hospital | Singapore | 119074 | Singapore |
| National Cancer Center | Singapore | 160610 | Singapore |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| D001855 |
| Bone Marrow Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |