- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Inqovi (decitabine/cedazuridine) / Otsuka
Trial initiation 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) - Aug 30, 2023 P1, N=24, Recruiting, Recruiting --> Active, not recruiting Initiation date: Aug 2023 --> Nov 2023
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date, 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) - Aug 3, 2023 P1/2, N=55, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Aug 2023 --> Aug 2024 | Trial primary completion date: Aug 2023 --> Aug 2024
- |||||||||| Review, Journal: Management of Patients with Lower-Risk Myelodysplastic Neoplasms (MDS). (Pubmed Central) - Aug 1, 2023
Several newer agents are being evaluated in phase 3 clinical trials for this group of patients, such as imetelstat and oral azacitidine. This review provides a summary of the classification systems, the prognostic scores and clinical management of patients with lower risk MDS.
- |||||||||| Review, Journal: Oral therapy for myelodysplastic syndromes/neoplasms and acute myeloid leukemia: a revolution in progress. (Pubmed Central) - Jul 20, 2023
The approvals of oral HMAs such as cedazuridine-decitabine (C-DEC) and oral azacitidine (CC-486) have kindled the hope that myeloid malignancies may soon be treated with total oral therapy...Oral HMAs have the potential to be a convenient and efficacy-equivalent treatment option for patients with HR-MDS or AML and improve their quality of life by reducing clinic visits for medication administration. Total-oral therapy combinations, largely including an oral HMA 'backbone,' are in the early phases of clinical development, and it is our hope that well-designed trials employing these agents may soon allow the identification of optimal regimens that deliver effective disease-directed therapy with good tolerability.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Inqovi (decitabine/cedazuridine) / Otsuka
Trial initiation 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) - Jul 14, 2023 P1, N=24, Recruiting, Total-oral therapy combinations, largely including an oral HMA 'backbone,' are in the early phases of clinical development, and it is our hope that well-designed trials employing these agents may soon allow the identification of optimal regimens that deliver effective disease-directed therapy with good tolerability. Initiation date: Mar 2023 --> Aug 2023
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion: Ascertain: Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML (clinicaltrials.gov) - May 31, 2023 P3, N=200, Completed, Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023 Active, not recruiting --> Completed
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - May 18, 2023 P1/2, N=188, Active, not recruiting, Active, not recruiting --> Recruiting N=124 --> 188 | Trial completion date: Jul 2024 --> Dec 2025 | Trial primary completion date: Jul 2024 --> Dec 2024
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Inqovi (decitabine/cedazuridine) / Otsuka
PHASE 1/2 STUDY OF ORAL DECITABINE/CEDAZURIDINE IN COMBINATION WITH VENETOCLAX IN TREATMENT-NA (Harmony 2) - May 12, 2023 - Abstract #EHA2023EHA_2335; P1/2 Pharmacokinetic, Oral, Peripheral T-cell lymphoma The combination of ASTX727 plus venetoclax is a promising, fully oral combination that is well-tolerated and demonstrates a high response rate in higher-risk MDS decitabine, Myelodysplastic syndrome, Venetoclax, Oral
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
PATIENTS (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_994; Survey results suggest very little/no impact on regular daily activities and improved quality-of-life with oral DEC-C relative to IV/SC HMAs, highlighting the potential for DEC-C to reduce the treatment burden associated with parenteral HMA therapy. Oral, Hypomethylating agents, Myelodysplastic syndrome, Quality of life
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, guadecitabine (SGI-110) / Otsuka, Inqovi (decitabine/cedazuridine) / Otsuka
IPSS-M PERFORMANCE IN PATIENTS WITH MYELODYSPLASTIC SYNDROME AT THE TIME OF HYPOMETHYLATING AGENT FAILURE (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_992; Despite the inclusion of molecular variables and patient stratification, the risk of death may be too high to be adequately captured.Figure 1. Kaplan-Meier survival function for overall survival of patients with HMA failure by IPSS-M categories with p-value for log-rank test.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy: Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm (clinicaltrials.gov) - Apr 26, 2023 P2, N=120, Recruiting, Clinical trial information: NCT05178693. Not yet recruiting --> Recruiting | Trial completion date: Aug 2024 --> Aug 2025 | Initiation date: Oct 2022 --> Apr 2023 | Trial primary completion date: Aug 2024 --> Aug 2025
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Therapeutic Targets in RAS-Mediated Proliferative CMML (Auditorium; Virtual) - Apr 25, 2023 - Abstract #MDS2023MDS_138; This study evaluated the perspectives of MDS patients receiving oral decitabine and cedazuridine (DEC-C), an alternative to IV/SC HMAs...Among patients who had previously received IV/SC HMAs (n=91), most agreed that DEC-C interfered less with daily life (91%) and had experienced improvement in quality-of-life (85%) compared with previous treatment; 91% reported that DEC-C reduced the number of times they needed to travel to a healthcare facility. Conclusions Survey results suggest very little/no impact on regular daily activities and improved quality-of-life with oral DEC-C relative to IV/SC HMAs, highlighting the potential for DEC-C to reduce the treatment burden associated with parenteral HMA therapy.
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
PATIENTS (Auditorium; Virtual) - Apr 25, 2023 - Abstract #MDS2023MDS_132; Among patients who had previously received IV/SC HMAs (n=91), most agreed that DEC-C interfered less with daily life (91%) and had experienced improvement in quality-of-life (85%) compared with previous treatment; 91% reported that DEC-C reduced the number of times they needed to travel to a healthcare facility . Conclusions Survey results suggest very little/no impact on regular daily activities and improved quality-of-life with oral DEC-C relative to IV/SC HMAs, highlighting the potential for DEC-C to reduce the treatment burden associated with parenteral HMA therapy.
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Trial primary completion date, Combination therapy: Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Apr 14, 2023 P1/2, N=124, Active, not recruiting, Conclusions Survey results suggest very little/no impact on regular daily activities and improved quality-of-life with oral DEC-C relative to IV/SC HMAs, highlighting the potential for DEC-C to reduce the treatment burden associated with parenteral HMA therapy. Trial primary completion date: Feb 2023 --> Jul 2024
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