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CC-486 Maintenance after Stem Cell Transplantation in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes.
de Lima M, Oran B, Champlin RE, Papadopoulos EB, Giralt SA, Scott BL, William BM, Hetzer J, Laille E, Hubbell B, Skikne BS, Craddock C. de Lima M, et al. Biol Blood Marrow Transplant. 2018 Oct;24(10):2017-2024. doi: 10.1016/j.bbmt.2018.06.016. Epub 2018 Jun 20. Biol Blood Marrow Transplant. 2018. PMID: 29933073 Free article. Clinical Trial.
Adults with MDS or AML in morphologic complete remission at CC-486 initiation (42 to 84 days after alloSCT) were included. Patients received 1 of 4 CC-486 dosing schedules per 28-day cycle for up to 12 cycles. ...CC-486 maintenance may pe …
Adults with MDS or AML in morphologic complete remission at CC-486 initiation (42 to 84 days after alloSCT) were included. Pat …
Extended dosing with CC-486 (oral azacitidine) in patients with myeloid malignancies.
Savona MR, Kolibaba K, Conkling P, Kingsley EC, Becerra C, Morris JC, Rifkin RM, Laille E, Kellerman A, Ukrainskyj SM, Dong Q, Skikne BS. Savona MR, et al. Am J Hematol. 2018 Oct;93(10):1199-1206. doi: 10.1002/ajh.25216. Epub 2018 Sep 3. Am J Hematol. 2018. PMID: 30016552 Free PMC article. Clinical Trial.
CC-486 (oral azacitidine) is an epigenetic modifier in clinical development for treatment of hematological cancers. ...Extended (21-day/cycle) CC-486 dosing induced responses in patients with hematological malignancies, many of whom had prior DNMTi fai
CC-486 (oral azacitidine) is an epigenetic modifier in clinical development for treatment of hematological cancers. ...Extende
Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia.
Roboz GJ, Montesinos P, Selleslag D, Wei A, Jang JH, Falantes J, Voso MT, Sayar H, Porkka K, Marlton P, Almeida A, Mohan S, Ravandi F, Garcia-Manero G, Skikne B, Kantarjian H. Roboz GJ, et al. Future Oncol. 2016 Feb;12(3):293-302. doi: 10.2217/fon.15.326. Epub 2016 Jan 19. Future Oncol. 2016. PMID: 26785287 Free PMC article.
The Phase III, randomized, double-blind, placebo-controlled QUAZAR AML Maintenance trial (CC-486-AML-001) examines CC-486 maintenance therapy (300 mg/day for 14 days of 28-day treatment cycles) for patients aged 55 years with AML in first complete remi …
The Phase III, randomized, double-blind, placebo-controlled QUAZAR AML Maintenance trial (CC-486-AML-001) examines CC- …
Oral Azacitidine (CC-486) for the Treatment of Myelodysplastic Syndromes and Acute Myeloid Leukemia.
Cogle CR, Scott BL, Boyd T, Garcia-Manero G. Cogle CR, et al. Oncologist. 2015 Dec;20(12):1404-12. doi: 10.1634/theoncologist.2015-0165. Epub 2015 Oct 13. Oncologist. 2015. PMID: 26463870 Free PMC article. Review.
Oral administration of azacitidine may enhance patient convenience, eliminate injection-site reactions, allow for alternative dosing and scheduling, and enable long-term treatment. Phase I studies with oral azacitidine (CC-486) have shown biological activity, clinic …
Oral administration of azacitidine may enhance patient convenience, eliminate injection-site reactions, allow for alternative dosing and sch …
An open-label, phase II multicohort study of an oral hypomethylating agent CC-486 and durvalumab in advanced solid tumors.
Taylor K, Loo Yau H, Chakravarthy A, Wang B, Shen SY, Ettayebi I, Ishak CA, Bedard PL, Abdul Razak A, R Hansen A, Spreafico A, Cescon D, Butler MO, Oza AM, Lheureux S, Stjepanovic N, Van As B, Boross-Harmer S, Wang L, Pugh TJ, Ohashi PS, Siu LL, De Carvalho DD. Taylor K, et al. J Immunother Cancer. 2020 Aug;8(2):e000883. doi: 10.1136/jitc-2020-000883. J Immunother Cancer. 2020. PMID: 32753546 Free PMC article.
PURPOSE: To evaluate whether administration of the oral DNA hypomethylating agent CC-486 enhances the poor response rate of immunologically 'cold' solid tumors to immune checkpoint inhibitor durvalumab. ...RESULTS: A total of 28 patients were enrolled, 19 patients t …
PURPOSE: To evaluate whether administration of the oral DNA hypomethylating agent CC-486 enhances the poor response rate of im …
Randomised phase 2 study of pembrolizumab plus CC-486 versus pembrolizumab plus placebo in patients with previously treated advanced non-small cell lung cancer.
Levy BP, Giaccone G, Besse B, Felip E, Garassino MC, Domine Gomez M, Garrido P, Piperdi B, Ponce-Aix S, Menezes D, MacBeth KJ, Risueño A, Slepetis R, Wu X, Fandi A, Paz-Ares L. Levy BP, et al. Eur J Cancer. 2019 Feb;108:120-128. doi: 10.1016/j.ejca.2018.11.028. Epub 2019 Jan 14. Eur J Cancer. 2019. PMID: 30654297 Clinical Trial.
Median treatment duration was shorter (15.0 versus 24.1 weeks), and the number of cycles was lower (5.0 versus 7.0) with pembrolizumab + CC-486 versus pembrolizumab + placebo. No new safety signals for CC-486 or pembrolizumab were detected. ...CONCLUSI …
Median treatment duration was shorter (15.0 versus 24.1 weeks), and the number of cycles was lower (5.0 versus 7.0) with pembrolizumab + …
Efficacy and safety of extended dosing schedules of CC-486 (oral azacitidine) in patients with lower-risk myelodysplastic syndromes.
Garcia-Manero G, Gore SD, Kambhampati S, Scott B, Tefferi A, Cogle CR, Edenfield WJ, Hetzer J, Kumar K, Laille E, Shi T, MacBeth KJ, Skikne B. Garcia-Manero G, et al. Leukemia. 2016 Apr;30(4):889-96. doi: 10.1038/leu.2015.265. Epub 2015 Oct 7. Leukemia. 2016. PMID: 26442612 Free PMC article. Clinical Trial.
CC-486 administered for 7 days per 28-day treatment cycle was evaluated in a phase 1 dose-finding study. ...RBC TI rates were similar with both dosing schedules (31% and 38%, respectively). CC-486 was generally well-tolerated. Extended dosing schedules
CC-486 administered for 7 days per 28-day treatment cycle was evaluated in a phase 1 dose-finding study. ...RBC TI rates were
CC-486 (oral azacitidine) in patients with myelodysplastic syndromes with pretreatment thrombocytopenia.
Garcia-Manero G, Scott BL, Cogle CR, Boyd TE, Kambhampati S, Hetzer J, Dong Q, Kumar K, Ukrainskyj SM, Beach CL, Skikne BS. Garcia-Manero G, et al. Leuk Res. 2018 Sep;72:79-85. doi: 10.1016/j.leukres.2018.08.001. Epub 2018 Aug 3. Leuk Res. 2018. PMID: 30114559 Free article. Clinical Trial.
Patients received CC-486 300 mg once-daily for 14 or 21 days of repeated 28-day cycles. ...Five thrombocytopenic patients attained complete remission and 9 attained platelet hematologic improvement. In both cohorts, platelet counts dropped during the first CC
Patients received CC-486 300 mg once-daily for 14 or 21 days of repeated 28-day cycles. ...Five thrombocytopenic patients atta …
Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors.
Von Hoff DD, Rasco DW, Heath EI, Munster PN, Schellens JHM, Isambert N, Le Tourneau C, O'Neil B, Mathijssen RHJ, Lopez-Martin JA, Edenfield WJ, Martin M, LoRusso PM, Bray GL, DiMartino J, Nguyen A, Liu K, Laille E, Bendell JC. Von Hoff DD, et al. Clin Cancer Res. 2018 Sep 1;24(17):4072-4080. doi: 10.1158/1078-0432.CCR-17-3716. Epub 2018 May 15. Clin Cancer Res. 2018. PMID: 29764853 Free PMC article. Clinical Trial.
The primary endpoint was safety, MTD, and recommended part 2 dose (RP2D) of CC-486. In part 2 (n = 112), the primary endpoint was the safety and tolerability of CC-486 administered at the RP2D for each treatment arm, in tumor-specific expansion cohorts …
The primary endpoint was safety, MTD, and recommended part 2 dose (RP2D) of CC-486. In part 2 (n = 112), the primary endpoint …
Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission.
Wei AH, Döhner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, Ravandi F, Sayar H, Jang JH, Porkka K, Selleslag D, Sandhu I, Turgut M, Giai V, Ofran Y, Kizil Çakar M, Botelho de Sousa A, Rybka J, Frairia C, Borin L, Beltrami G, Čermák J, Ossenkoppele GJ, La Torre I, Skikne B, Kumar K, Dong Q, Beach CL, Roboz GJ; QUAZAR AML-001 Trial Investigators. Wei AH, et al. N Engl J Med. 2020 Dec 24;383(26):2526-2537. doi: 10.1056/NEJMoa2004444. N Engl J Med. 2020. PMID: 33369355 Clinical Trial.
Median relapse-free survival was also significantly longer with CC-486 than with placebo (10.2 months and 4.8 months, respectively; P<0.001). ...Overall health-related quality of life was preserved during CC-486 treatment. CONCLUSIONS: CC- …
Median relapse-free survival was also significantly longer with CC-486 than with placebo (10.2 months and 4.8 months, respecti …
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