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Study Title Principal Investigator
A Phase1-2 Pharmacokinetic Guided Dose-Escalation and Dose-Confirmation Study of ASTX727, a Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 With Oral Decitabine in Subjects With Myelodysplastic Syndromes (MDS)
Dose levels for the study's second stage will be based on safety and pharmacokinetics.
Recruiting | Myelodysplastic Syndromes (MDS) | Multisite
Mohammad Azab
A Phase 1b/2 Study To Evaluate The Safety And Efficacy Of Pf-04449913, An Oral Hedgehog Inhibitor, In Combination With Intensive Chemotherapy, Low Dose Ara-c Or Decitabine In Patients With Acute Myeloid Leukemia Or High-risk Myelodysplastic Syndrome
Recruiting | Leukemia | Multisite
Pfizer Center
A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent
This is a Phase III, open-label, randomized, controlled, international study (approximately 100 sites). Approximately 225 patients < 80 years of age with MDS classified as RAEB-1, RAEB-2, or RAEB-t who received AZA or DEC for ≤ 9 months and had their last dose of AZA or DEC within 6 months prior to screening will be stratified by: - Very high risk (VHR) vs non-VHR per IPSS-R, and - Geographic region (North America vs Europe vs Asia; because approved products and standard of care may vary by region), and randomly assigned in a 2:1 ratio to one of the following 2 treatment groups: - Rigosertib 1800 mg/24 hr administered as a 72 hr CIV infusion on Days 1, 2, and 3 of a 2 week cycle for the first 8 cycles, and on Days 1, 2, and 3 of a 4-week cycle thereafter (N = approximately 150 patients); - Physician's Choice of alternative treatment, which may include any approved or standard-of-care therapy, based on frequently used treatment for MDS after receipt of HMAs (N = approximately 75 patients). Experimental therapies are not allowed on the PC arm. Patients will be treated until 2006 IWG progression criteria are met (ie, 50% increase of BM blasts or worsening of cytopenias) or until an unacceptable toxicity or intolerance. For all randomized patients who discontinue study treatment, subsequent therapies with their start and end dates, as well as survival time after treatment discontinuation, will be documented at least monthly until death. Patients in the PC group who progress will not be allowed to cross over to rigosertib. All patients in both treatment groups will be allowed, as medically justified, access to RBC and platelet transfusions and to growth factors (granulocyte colony-stimulating factor (G-CSF), erythropoietin, and thrombopoietin).
Recruiting | Myelodysplastic Syndromes (MDS) | Multisite
Steven Fruchtman
9L-14-6: A Randomized, Double-Blind Phase 1b/2 Study of PF-04449913 in Combination with Azacitidine in Patients with Previously Untreated Intermediate-2 or High-Risk Myelodysplastic Syndrome, Acute Myeloid Leukemia with 20-30% Blasts and Multi-Lineage Dysplasia, or Chronic Myelomonocytic Leukemia
PF-04449913 is a novel small molecule inhibitor of the Sonic Hedgehog (Hh) Pathway which is currently under development for the treatment of hematologic malignancies and solid tumors.This multi-center randomized (1:1), double-blind, placebo-controlled Phase 1b/2 study is designed to compare the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04449913 or placebo when combined with azacitidine in patients with previously untreated Intermediate-2 or High-Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage dysplasia, and Chronic Myelomonocytic Leukemia (CMML).This clinical study includes two components: (a) a Phase 1b safety lead-in and (b) a randomized Phase 2.Primary Objective is to assess the safety and tolerability of PF-04449913 when administered in combination with azacitidinePrimary endpoint is adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
Recruiting | Myelodysplastic Syndromes (MDS) | Multisite
Casey O'Connell
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