CLINICAL TRIALS PROFILE FOR GUADECITABINE

Clinical Trials for Guadecitabine

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01696032 ↗	SGI-110 in Combination With Carboplatin in Ovarian Cancer	Completed	Astex Pharmaceuticals	Phase 2	A 2-part, Phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on safety and efficacy. In Part 2, participants were randomized to receive the dose identified in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the investigator. The treatment of choice consisted of topotecan, pegylated liposomal doxorubicin, paclitaxel or gemcitabine.
NCT01696032 ↗	SGI-110 in Combination With Carboplatin in Ovarian Cancer	Completed	Astex Pharmaceuticals, Inc.	Phase 2	A 2-part, Phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on safety and efficacy. In Part 2, participants were randomized to receive the dose identified in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the investigator. The treatment of choice consisted of topotecan, pegylated liposomal doxorubicin, paclitaxel or gemcitabine.
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Astex Pharmaceuticals, Inc.	Phase 1/Phase 2	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Van Andel Research Institute	Phase 1/Phase 2	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Sidney Kimmel Comprehensive Cancer Center	Phase 1/Phase 2	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 1/Phase 2	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).

Clinical Trial Conditions for Guadecitabine

Condition Name

Condition Name for
Intervention	Trials
Acute Myeloid Leukemia	6
Leukemia	3
Myelodysplastic Syndromes	3
High Risk Myelodysplastic Syndrome	2

Condition MeSH

Condition MeSH for
Intervention	Trials
Leukemia, Myeloid, Acute	9
Leukemia	8
Preleukemia	6
Myelodysplastic Syndromes	6

Clinical Trial Locations for Guadecitabine

Trials by Country

Trials by Country for
Location	Trials
United States	124
Canada	14
France	12
Poland	8
Germany	8

Trials by US State

Trials by US State for
Location	Trials
California	12
New York	11
Pennsylvania	11
Texas	10
Maryland	9

Clinical Trial Progress for Guadecitabine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	13
Phase 1/Phase 2	6

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Active, not recruiting	11
Completed	9
Not yet recruiting	3

Clinical Trial Sponsors for Guadecitabine

Sponsor Name

Sponsor Name for
Sponsor	Trials
Astex Pharmaceuticals	13
Astex Pharmaceuticals, Inc.	12
National Cancer Institute (NCI)	10

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	35
Other	33
NIH	10