Last updated on October 2017

Phase II Part 2 Expansion of Oral Rigosertib in Combination With Azacitidine


Brief description of study

This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase II, Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. The first two parts have been completed. The Phase II, Part 2 Expansion will assess if treatment with rigosertib in combination with azacitidine, has measurable effects in patients with myelodysplastic syndrome (MDS). Safety of patients is an objective throughout all parts of the study.

Detailed Study Description

This will be a Phase I/II open-label, single-arm, dose-escalating, multicenter study, in three parts: Phase I Dose Escalation, Phase II, Part 1 RPTD Cohort, and Phase II, Part 2 Expansion, in which patients with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or chronic myelomonocytic leukemia (CMML) will receive subcutaneous (SC) or intravenous (IV) azacitidine per approved label in combination with oral rigosertib. The first two parts of the study have been completed. The Phase II Part 2 Expansion will enroll up to 40 patients, randomized 1:1 into 2 cohorts of up to 20 patients each, to receive 1120 mg of rigosertib over 24 hours: either 560 mg in the morning and 560 mg in the afternoon, or 840 mg in the morning and 280 mg in the afternoon. The afternoon dose in both cohorts must be administered at 3 PM (±1 hr) at least 2 hr after lunch. In the Phase II, Part 2 Expansion patients with RAEB t/non-proliferative AML will be eligible, however patients with CMML will not.

Clinical Study Identifier: NCT01926587

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Samer Khaled, MD

City of Hope
Duarte, CA United States
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David E. Young, MD

Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, CA United States
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Jamile Shammo, MD

Rush University Medical Center
Chicago, IL United States
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M. Nabeel Rajeh, MD

Saint Louis University
Saint Louis, MO United States
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Shyamala Navada, MD

Mount Sinai Medical Center
New York, NY United States
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Dan Costin, MD

White Plains Hospital Center for Cancer Care
White Plains, NY United States
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Sashi Naidu, MD

Carolina Blood and Cancer Care Associates
Rock Hill, SC United States
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Guillermo Garcia-Manero, MD

The University of Texas MD Anderson Cancer Center
Houston, TX United States
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Ehab Atallah, MD

Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, WI United States
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Joseph Morgan, MD

H pital St. Louis
Paris, France
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