Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01928537 | Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine | PHASE3 | COMPLETED | 67 | — | — | Aug 1, 2013 | Jun 29, 2017 | Jun 30, 2020 | 35 | United States, Australia +6 |
| NCT01904682 | Oral Rigosertib in Low Risk MDS Patients Refractory to ESAs | PHASE2 | COMPLETED | 45 | — | — | Jul 1, 2013 | May 1, 2021 | Jun 16, 2021 | 14 | United States, France +1 |
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 and overall survival. 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.
The number of patients who achieve hematologic improvement will be documented. Hematologic improvement is defined by the 2006 International Working Group (IWG) response criteria for the erythroid, platelet and neutrophil lineages.
| Arm | Type | Description |
|---|---|---|
| rigosertib sodium | EXPERIMENTAL | 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. |
| Oral rigosertib | EXPERIMENTAL | Patients will take 560 mg oral rigosertib (two 280 mg capsules) in the morning and 280 mg (one 280 mg capsule) in the afternoon, in fasting conditions, for 21 consecutive days of 21-day cycle (continuous regimen). |
| Name | Type | Description |
|---|---|---|
| rigosertib sodium | DRUG | - |
| Oral rigosertib | DRUG | Dose of 560 mg consists of two (2) 280 mg soft gel capsules of rigosertib. |
Inclusion Criteria: * Diagnosis of MDS confirmed within 6 weeks prior to Screening according to WHO criteria or French-American-British (FAB) classification. * MDS classified as follows, according to WHO criteria and FAB classification: * RAEB-1 (5% to 9% BM blasts) * RAEB-2 (10% to 19% BM bla...