Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine
|ClinicalTrials.gov Identifier: NCT01928537|
Recruitment Status : Active, not recruiting
First Posted : August 26, 2013
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes Refractory Anemia With Excess Blasts Chronic Myelomonocytic Leukemia Cytopenia||Drug: rigosertib sodium||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IIIB, Open-label, Multi-Center Study of the Efficacy and Safety of Rigosertib Administered as 72-hour Continuous Intravenous Infusions in Patients With Myelodysplastic Syndrome With Excess Blasts Progressing On or After Azacitidine or Decitabine|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: rigosertib sodium
Rigosertib sodium will be administered as a 72-hr continuous intravenous infusion consisting of 3 consecutive doses of 1800 mg over 24 hours on Days 1, 2, and 3 of a 14-day cycle for the first 8 cycles and then on Days 1, 2, and 3 of a 28-day cycle for the following cycles.
Drug: rigosertib sodium
- Relationship of bone marrow blast response and overall survival. [ Time Frame: Up to 2 years. ]Bone marrow blast response is defined as bone marrow (BM) complete response, ≥ 50% BM blast decrease from pretreatment value, or stable BM response (no progression) according to the International Working Group (IWG) 2006 criteria. Overall survival is defined as the time from first study treatment to death from any cause. All patients will be followed until death and/or progression, even if they have discontinued treatment for whatever cause. Survival time of patients lost to follow-up will be censored at the time they were last known to be alive.
- Number of patients with overall hematologic response. [ Time Frame: Up to 2 years after study enrollment. ]Overall hematologic response (complete remission [CR], partial remission [PR], bone marrow complete response [BMCR], and stable disease [SD]) is defined according to 2006 International Working Group (IWG) response criteria.
- Number of patients with hematological improvement. [ Time Frame: Up to 2 years after study enrollment. ]Hematological improvement (erythroid response, platelet response and neutrophil response) is defined according to 2006 International Working Group (IWG) response criteria.
- Number of patients with cytogenetic response. [ Time Frame: Up to 2 years after study enrollment. ]Cytogenetic response is defined according to 2006 International Working Group (IWG) response criteria.
- Progression-free survival. [ Time Frame: Up to 2 years after study enrollment. ]Progression-free survival is defined as time from date of first dose until date when progression is documented. Progression is defined according to 2006 International Working Group (IWG) response criteria.
- Number of patients who transition to Acute Myeloid Leukemia (AML) [ Time Frame: Up to 2 years after study enrollment. ]Participants who progress to Acute Myeloid Leukemia (AML) during the study. AML is defined as an increase of at least 50% bone marrow blasts, and more than 20% bone marrow blasts for Refractory Anemia with Excess Blasts types 1 and 2 (RAEB-1 and RAEB-2) and Chronic Myelomonocytic Leukemia (CMML) patients and as an increase of at least 50% bone marrow blasts for Refractory Anemia with Excess Blasts in Transformation (RAEB-t) patients.
- Quality of Life Questionnaire [ Time Frame: Up to 2 years after study enrollment. ]Change from baseline in responses in the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30 version 3. Questionnaire will be administered at baseline and at 4 week intervals.
- Infections. [ Time Frame: Up to 2 years after study enrollment. ]Incidence of infections requiring treatment with intravenous antimicrobials and of bleeding episodes.
- Concentration of rigosertib in plasma. [ Time Frame: Week 1 and week 3. ]Concentration of rigosertib in plasma will be measured by a validated High Performance Liquid Chromatography (HPLC) method.
- Safety. [ Time Frame: Study enrollment until 30 days after patient's last dose of rigosertib up to 2 years. ]Counts of patients who have adverse events (AEs). Adverse events will be grouped by system organ class (SOC) and preferred term (PT) using the most recent version of the Medical Dictionary for Regulatory Activities (MedDRA), and will be summarized by worst grade according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928537
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|Study Chair:||Steven M. Fruchtman, MD||Onconova Therapeutics, Inc.|