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- ||| Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: GFM-DACORAL-DLI: ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients (clinicaltrials.gov) - Apr 7, 2023
P2, N=57, Active, not recruiting, Sponsor: Groupe Francophone des Myelodysplasies
Recruiting --> Active, not recruiting | N=40 --> 57 | Trial completion date: Jan 2025 --> Apr 2025 | Trial primary completion date: Jan 2023 --> Apr 2024
- |||| Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
New P2 trial, Combination therapy: Decitabine and Cedazuridine in Combination With Venetoclax for the Treatment of Patients Who Have Relapsed Acute Myeloid Leukemia After Donor Stem Cell Transplant (clinicaltrials.gov) - Apr 5, 2023
P2, N=51, Not yet recruiting, Sponsor: Sanjay Mohan
- | Onureg (azacitidine oral) / BMS
Journal: Ascertaining QUAZARs: slow-motion and light-speed development of oral azacitidine and decitabine. (Pubmed Central) - Mar 24, 2023
We will discuss the development of these oral HMAs, including the advantages/disadvantages in transitioning to oral HMAs and an in depth look at the pivotal phase III trials that led to their FDA approval - ASCERTAIN for DC and QUAZAR-AML-001 for CC-486. We also review how these agents have been and are being studied in other malignancies, and examine the future role that these exciting novel agents will play in both MDS and AML.
- | Venclexta (venetoclax) / Roche, AbbVie, Xospata (gilteritinib) / Astellas, Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date: NCI-2021-06095: ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Mar 16, 2023
P1/2, N=42, Recruiting, Sponsor: M.D. Anderson Cancer Center
We also review how these agents have been and are being studied in other malignancies, and examine the future role that these exciting novel agents will play in both MDS and AML. Trial completion date: Jan 2023 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Jan 2025
- | Keytruda (pembrolizumab) / Merck (MSD), Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open, Trial completion date, Trial primary completion date, Metastases: Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Mar 16, 2023
P1, N=24, Recruiting, Sponsor: National Cancer Institute (NCI)
Trial completion date: Jan 2023 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Jan 2025 Not yet recruiting --> Recruiting | Trial completion date: Oct 2024 --> Feb 2027 | Trial primary completion date: Oct 2024 --> Feb 2027
- || imetelstat (GRN163L) / Geron, Reblozyl (luspatercept-aamt) / BMS, Merck (MSD), Inqovi (decitabine/cedazuridine) / Otsuka
Why the last? This chapter was written years ago, before the IPSS-M, before the 5th edition WHO, before the ICC, before important new biological and genetic discoveries, before luspatercept and ASTX727 approval, and potentially imetelstat soon. So it’s already partly obsolete. (Twitter) - Mar 4, 2023
- || Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date: ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase (clinicaltrials.gov) - Feb 24, 2023
P2, N=70, Recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting | Trial completion date: Oct 2024 --> Feb 2027 | Trial primary completion date: Oct 2024 --> Feb 2027 Trial completion date: Oct 2022 --> Oct 2023 | Trial primary completion date: Oct 2022 --> Oct 2023
- | Imfinzi (durvalumab) / AstraZeneca, Inqovi (decitabine/cedazuridine) / Otsuka
Trial primary completion date, Combination therapy, Monotherapy, IO biomarker, Metastases: Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients (clinicaltrials.gov) - Feb 21, 2023
P1/2, N=13, Active, not recruiting, Sponsor: Massachusetts General Hospital
Trial completion date: Oct 2022 --> Oct 2023 | Trial primary completion date: Oct 2022 --> Oct 2023 Trial primary completion date: Jan 2023 --> Jul 2023
- | Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date: Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment (clinicaltrials.gov) - Feb 21, 2023
P1b, N=18, Recruiting, Sponsor: Astex Pharmaceuticals, Inc.
Trial primary completion date: Jan 2023 --> Jul 2023 Trial completion date: Jan 2023 --> Dec 2023 | Trial primary completion date: Jan 2023 --> Dec 2023
- | Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment change, Combination therapy, Tumor mutational burden: NCI-2021-02246: Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients (clinicaltrials.gov) - Jan 30, 2023
P1/2, N=55, Recruiting, Sponsor: National Cancer Institute (NCI)
Trial completion date: Jan 2023 --> Dec 2023 | Trial primary completion date: Jan 2023 --> Dec 2023 N=18 --> 55
- | Inqovi (decitabine/cedazuridine) / Otsuka
Journal: Reversible cardiomyopathy in a patient with chronic myelomonocytic leukemia treated with decitabine/cedazuridine: a case report. (Pubmed Central) - Jan 20, 2023
We present an occurrence of reversible cardiomyopathy in a patient who completed 5 cycles of decitabine/cedazuridine, an oral combination therapy developed to enhance oral bioavailability of decitabine thereby limiting its adverse effects. As the decitabine/cedazuridine combination therapy rises in popularity due to its convenient oral formulation, more trials are needed to understand the prevalence of cardiomyopathy with this drug and to discover preventative strategies for cardiotoxic effects.
- || Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date: Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant (clinicaltrials.gov) - Jan 19, 2023
P1/2, N=126, Recruiting, Sponsor: Washington University School of Medicine
As the decitabine/cedazuridine combination therapy rises in popularity due to its convenient oral formulation, more trials are needed to understand the prevalence of cardiomyopathy with this drug and to discover preventative strategies for cardiotoxic effects. Trial completion date: May 2025 --> Nov 2033 | Trial primary completion date: May 2025 --> Nov 2033
- | defactinib (VS-6063) / Verastem, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open, Combination therapy: CELESTIAL-MDS: Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS (clinicaltrials.gov) - Jan 13, 2023
P1, N=12, Recruiting, Sponsor: Clinical Hub for Interventional Research (CHOIR)
Trial completion date: May 2025 --> Nov 2033 | Trial primary completion date: May 2025 --> Nov 2033 Not yet recruiting --> Recruiting
- | Keytruda (pembrolizumab) / Merck (MSD), Inqovi (decitabine/cedazuridine) / Otsuka
New P1 trial, Metastases: Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Jan 6, 2023
P1, N=24, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- | decitabine / Generic mfg.
Trial completion date, Trial primary completion date: Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors (clinicaltrials.gov) - Jan 5, 2023
P1, N=30, Recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Not yet recruiting --> Recruiting Trial completion date: Jan 2023 --> Jun 2023 | Trial primary completion date: Jan 2023 --> Jun 2023
- | Beleodaq (belinostat) / Aurobindo, Assertio, guadecitabine (SGI-110) / Otsuka, Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date, Metastases: ETCTN: Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (clinicaltrials.gov) - Jan 4, 2023
P2, N=32, Suspended, Sponsor: National Cancer Institute (NCI)
Trial completion date: Jan 2023 --> Jun 2023 | Trial primary completion date: Jan 2023 --> Jun 2023 Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
- tolinapant (ASTX660) / Otsuka, Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date, Combination therapy: A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Jan 4, 2023
P1, N=68, Terminated, Sponsor: Astex Pharmaceuticals, Inc.
Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024 Trial completion date: Aug 2022 --> Jan 2022 | Trial primary completion date: Aug 2022 --> Jan 2022
- ||| Inqovi (decitabine/cedazuridine) / Otsuka
Check out abstract using #PO_decitabine 💊 #Inqovi in #MDS. 👉🏻 mOS 25 mons in #TP53m 🧬 👉🏻 mOS 13 mons in Bi-Allelic #TP53m @MayoCancerCare @MDAndersonNews #MDSsm https://t.co/cnIucoPWlG #ASH22 (Twitter) - Dec 12, 2022
- ||| Inqovi (decitabine/cedazuridine) / Otsuka
Reimbursement: Do you guys have trouble getting Inqovi + Ven approved through insurance? (Twitter) - Dec 11, 2022
- || Inqovi (decitabine/cedazuridine) / Otsuka
Review, Journal: Decitabine/cedazuridine for chronic myelomonocytic leukaemia, myelodysplastic syndromes. (Pubmed Central) - Dec 9, 2022
Trial completion date: Aug 2022 --> Jan 2022 | Trial primary completion date: Aug 2022 --> Jan 2022 No abstract available
- | Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date, Combination therapy: Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) - Dec 9, 2022
P2, N=40, Recruiting, Sponsor: M.D. Anderson Cancer Center
No abstract available Trial completion date: Oct 2022 --> Oct 2023 | Trial primary completion date: Oct 2022 --> Oct 2023
- | defactinib (VS-6063) / Verastem, Inqovi (decitabine/cedazuridine) / Otsuka
New P1 trial, Combination therapy: CELESTIAL-MDS: Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS (clinicaltrials.gov) - Dec 5, 2022
P1, N=12, Not yet recruiting, Sponsor: Clinical Hub for Interventional Research (CHOIR)
- tolinapant (ASTX660) / Otsuka, Inqovi (decitabine/cedazuridine) / Otsuka
A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma () - Nov 29, 2022 - Abstract #ASH2022ASH_7426;
P1/2
In Phase 2, there will be efficacy analysis for every 34 subjects, without a pause in enrollment. Study initiated in May 2022.
- tolinapant (ASTX660) / Otsuka
Tolinapant, a Non-Peptidomimetic Antagonist of Inhibitors of Apoptosis Proteins, cIAP1/2 and XIAP, in Combination with the Hypomethylating Agents, Azacytidine and Decitabine Are Highly Synergistic in in Vitro Models of T Cell Lymphoma () - Nov 29, 2022 - Abstract #ASH2022ASH_7172;
P1/2
Thus, activation of the necroptosis pathway, is a possible mechanism for the high degree of synergy displayed when HMAs are used in combination with tolinapant in the TCL lines in vitro. These data provided the rationale for a phase 1-2 study of the combination of tolinapant and oral decitabine/cedazuridine treatment in relapsed/refractory PTCL (NCT05403450).
- || Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment closed: ASTX727-03: Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS (clinicaltrials.gov) - Nov 22, 2022
P1/2, N=160, Active, not recruiting, Sponsor: Astex Pharmaceuticals, Inc.
These data provided the rationale for a phase 1-2 study of the combination of tolinapant and oral decitabine/cedazuridine treatment in relapsed/refractory PTCL (NCT05403450). Recruiting --> Active, not recruiting
- Inqovi (decitabine/cedazuridine) / Otsuka
MM1OA-S02: A Phase 2 Study of Targeted Agents with the Oral DNMT1 Inhibitor C-DEC (ASTX727) for the Treatment of TP53-Mutated Acute Myeloid Leukemia: A myeloMATCH treatment trial (Regency C (Ballroom Level, West Tower)) - Nov 15, 2022 - Abstract #SWOGFall2022SWOG_Fall_8;
- || Inqovi (decitabine/cedazuridine) / Otsuka
https://t.co/4CYwO3bdH9 #ASH22 Prolonged Survival in Bi-Allelic TP53-Mutated (TP53mut) MDS Subjects Treated with Oral Decitabine/Cedazuridine in the Ascertain Trial (ASTX727-02) (Twitter) - Nov 13, 2022
- || Rozlytrek (entrectinib) / Roche, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open, Combination therapy: Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia (clinicaltrials.gov) - Nov 9, 2022
P1, N=12, Recruiting, Sponsor: OHSU Knight Cancer Institute
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Trial initiation date: MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (clinicaltrials.gov) - Nov 7, 2022
P2, N=750, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Initiation date: Oct 2022 --> Feb 2023
- |||||| Combination therapy: Oral Decitabine/Cedazuridine (ASTX727) and Venetoclax in Combination with the Targeted Mutant IDH1 Inhibitor Ivosidenib or the Targeted Mutant IDH2 Inhibitor Enasidenib in IDH Mutated Acute Myeloid Leukemia https://t.co/V1fZGadcpA #AML #ASH22 (Twitter) - Nov 6, 2022
- magrolimab (GS-4721) / Ono Pharma, Gilead, Inqovi (decitabine/cedazuridine) / Otsuka
Phase 2 Study of Oral Decitabine/Cedazuridine in Combination with Magrolimab for Previously Untreated Subjects with Intermediate to Very High-Risk Myelodysplastic Syndromes (MDS) (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_6217;
P3
Approximately 100 subjects will be enrolled. Anticipated study opening is November 2022.
- Venclexta (venetoclax) / Roche, AbbVie, Xospata (gilteritinib) / Astellas, Inqovi (decitabine/cedazuridine) / Otsuka
A Phase I/II Study of Combination of ASTX727, Gilteritinib and Venetoclax in Patients with Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia (AML) and Frontline FLT3 Mutated AML Patients Unfit for Chemotherapy (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_5878;
Myelosuppression was frequent but manageable. Continued accrual is anticipated to define the optimal triplet regimen in both R/R and newly diagnosed FLT3-mutated AML.
- Inqovi (decitabine/cedazuridine) / Otsuka
Prolonged Survival in Bi-Allelic TP53-Mutated (TP53mut) MDS Subjects Treated with Oral Decitabine/Cedazuridine in the Ascertain Trial (ASTX727-02) (ENMCC - 243-245) - Nov 4, 2022 - Abstract #ASH2022ASH_5242;
The NGS mutational profile of MDS and CMML subjects in the ASCERTAIN trial included 35% with TP53mut and this group had a worse survival than those with WT TP53 apparently driven by the poor outcome of those with BA TP53mut. Further LOH studies will help refine this analysis, but in this conservative estimate, treatment with oral decitabine/cedazuridine in the ASCERTAIN study resulted in an estimated survival of 13 months for BA TP53mut which compares favorably with historical results.
- Phase Ib/2 Study of Oral Decitabine/Cedazuridine (ASTX727) and Venetoclax in Combination with the Targeted Mutant IDH1 Inhibitor Ivosidenib or the Targeted Mutant IDH2 Inhibitor Enasidenib in IDH Mutated Acute Myeloid Leukemia (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4176;
(Table 1) In the R/R cohort, 78% (n=11) patients had received prior treatment with either an HMA (azacitidine or decitabine), BCL2i and/or IDHi, with a median of 2 prior treatments...There were two patients with possible/probable differentiation syndrome which resolved with medical management (dexamethasone and diuresis)...AEs are anticipated and tolerable. Enrollment to this study is ongoing.
- Inqovi (decitabine/cedazuridine) / Otsuka
ASTX727-03: Phase 1 Study Evaluating Oral Decitabine/Cedazuridine (ASTX727) Low-Dose (LD) in Lower-Risk Myelodysplastic Syndromes (LR-MDS) Patients (ENMCC - R06-R09) - Nov 4, 2022 - Abstract #ASH2022ASH_3673;
Based on the results of the Phase 1 study, the dosing schedule of 10 mg DEC / 100 mg CED daily for 5 days, that balanced clinical efficacy with an acceptable and manageable safety profile was selected as the RP2D. This regimen will be compared to 35 mg DEC / 100 mg CED for 3 days in a 28-day cycle in the ongoing Phase 2 study.
- sabatolimab (MBG453) / Novartis
Stimulus MDS-US Trial in Progress: Evaluating Sabatolimab in Combination with Hypomethylating Agents (HMAs) in Patients with Intermediate-, High-, or Very High–Risk Myelodysplastic Syndrome (MDS) (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_2631;
P1b, P2
Primary end points are incidence and severity of adverse events (AEs) and serious AEs. Secondary endpoints are complete remission (CR) rate (according to International Working Group for the Prognosis for MDS), progression-free survival, overall survival, leukemia-free survival, percentage of patients with CR, marrow CR and/or partial remission, duration of CR, time to CR, and percentage of patients with improvement in red blood cell/platelet transfusion independence.
- Inqovi (decitabine/cedazuridine) / Otsuka
Treatment Patterns and Characteristics Among Patients with Myelodysplastic Syndromes Initiating Oral Decitabine and Cedazuridine or Intravenous/Subcutaneous Hypomethylating Agents in a Real-World Setting (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_2621;
Characteristics were similar among patients initiating DEC-C and IV/SC HMAs; data also suggest ongoing off-label use of HMAs post-HSCT transplant and in AML. The similar number of HMA claims between groups suggests comparable compliance with oral therapy at home vs IV/SC treatment in the clinical setting, with a possible advantage of DEC-C in reducing the treatment burden associated with existing IV/SC HMA therapy.
- ALLG AMLM26 Phase 1B/2 Study Investigating Novel Therapies to Target Early Relapse and Clonal Evolution As Pre-Emptive Therapy in AML (INTERCEPT): A Multi-Arm, Precision-Based, Recursive, Platform Trial (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_2286;
Where no specific targeted treatment is available, patients will be randomly allocated to non-targeted therapies, if more than one applicable arm exists, to arms including sabatolimab, sabatolimab + azacitidine, ASTX727 + VEN or LDAC + VEN...Key secondary endpoints will be nadir MRD response, MRD clearance rate, median time to and duration of MRD response, relapse-free survival, overall survival and quality of life measures. Exploratory objectives will include analysis of drug resistance mechanisms and correlates of response.
- Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
Phase 2 Study of ASTX727 (cedazuridine/decitabine) Plus Venetoclax in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Previously Untreated, Elderly Patients with AML Unfit for Chemotherapy (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_2280;
ASTX727 and venetoclax combination is safe and feasible particularly in the advanced elderly population and demonstrates significant efficacy in pts unfit for chemotherapy both in the FL and R/R settings. Total oral therapy of ASTX727 and venetoclax combination appears to be a promising strategy for older and unfit patients with AML.
- Venclexta (venetoclax) / Roche, AbbVie
Maintenance Therapy with Venetoclax/Azacitidine Can be Safely Given after Venetoclax/FluBu2 RIC Allogeneic Transplantation for the Treatment of High Risk MDS/AML: Results of a Phase 1 Study (ENMCC - 353-355) - Nov 4, 2022 - Abstract #ASH2022ASH_1799;
P1
This Ven-based peri-transplant strategy for high risk MDS/AML pts has encouraging activity though relapses still occurred. A cohort assessing all oral maintenance (Ven plus decitabine/cedazuridine) is enrolling.
- | Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
New P2 trial, Combination therapy: Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm (clinicaltrials.gov) - Nov 1, 2022
P2, N=120, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- || Venclexta (venetoclax) / Roche, AbbVie, revumenib (SNDX-5613) / Syndax Pharma, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open: A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE) (clinicaltrials.gov) - Oct 18, 2022
P1/2, N=43, Recruiting, Sponsor: M.D. Anderson Cancer Center
A cohort assessing all oral maintenance (Ven plus decitabine/cedazuridine) is enrolling. Not yet recruiting --> Recruiting
- || Rozlytrek (entrectinib) / Roche, Inqovi (decitabine/cedazuridine) / Otsuka
Trial initiation date, Combination therapy: Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia (clinicaltrials.gov) - Oct 13, 2022
P1, N=12, Not yet recruiting, Sponsor: OHSU Knight Cancer Institute
Not yet recruiting --> Recruiting Initiation date: Jun 2022 --> Oct 2022
- |||| Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment closed, Trial completion date: Ascertain: Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML (clinicaltrials.gov) - Oct 10, 2022
P3, N=200, Active, not recruiting, Sponsor: Astex Pharmaceuticals, Inc.
Initiation date: Jun 2022 --> Oct 2022 Completed --> Active, not recruiting | Trial completion date: May 2022 --> Mar 2023
- ||||| NDA: #MyeloDisplastikSendrom: 2023 tedavi paradigması #MDS 2023 tedavi modeli: Luspatercept, Cedazuridine, Decitabine, Azacitidine, Eltrombopag, Romiplostim, Transplantasyon, Lenalidomide, ATG... Yerinde ve zamanında… #hematoloji #transplantasyon #kokhucrenakli #profdrfevzialtuntas (Twitter) - Oct 9, 2022
- || Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment closed, Combination therapy: Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Oct 6, 2022
P1/2, N=124, Active, not recruiting, Sponsor: Astex Pharmaceuticals, Inc.
Completed --> Active, not recruiting | Trial completion date: May 2022 --> Mar 2023 Recruiting --> Active, not recruiting
- | New P2 trial: MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (clinicaltrials.gov) - Oct 3, 2022
P2, N=750, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- || itacitinib (INCB039110) / Incyte, Inqovi (decitabine/cedazuridine) / Otsuka
Clinical, P1/2 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: The ABNL-MARRO 001 study: a phase 1-2 study of randomly allocated active myeloid target compound combinations in MDS/MPN overlap syndromes. (Pubmed Central) - Sep 29, 2022
P1/2
Recruiting --> Active, not recruiting Beyond the primary objectives of the study to evaluate the safety and efficacy of novel treatment combinations in MDS/MPN, the study will (i) Establish the ABNL MARRO infrastructure for future prospective studies, (ii) Forge innovative scientific research that will improve our understanding of pathogenetic mechanisms of disease, and (iii) Inform the clinical application of diagnostic criteria, risk stratification and prognostication tools, as well as response assessments in this heterogeneous patient population.
- || Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
P2 data, Clinical Trial,Phase II, Journal: AML-328 Phase 2 Study of ASTX727 (Decitabine/Cedazuridine) Plus Venetoclax in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Previously Untreated, Older Adult Patients Unfit for Chemotherapy. (Pubmed Central) - Sep 29, 2022
ASTX727 and venetoclax combination is safe and feasible and demonstrates significant efficacy in pts unfit for chemotherapy. Research funding by Taiho.