Drugs / CC-486

Trials 16

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT04639843 Nov 2022 adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, extranodal nasal NK/T cell lymphoma, hepatosplenic T-cell lymphoma +1 National Cancer Institute (NCI) Withdrawn No outcome recorded
Phase 1 NCT04887857 Dec 2021 → Jan 2024 acute myeloid leukemia Celgene Corporation Completed No outcome recorded
Phase 1 NCT02512172 Feb 2016 → Nov 2021 colorectal cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 1 NCT01478685 Nov 2011 → Nov 2015 fallopian tube neoplasm, non-small cell lung carcinoma, ovarian neoplasm, pancreatic ductal adenocarcinoma +4 Celgene Corporation Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT04722601 Sep 2021 → Mar 2023 follicular lymphoma University of Chicago Terminated No outcome recorded Stop: Business
Phase 1/2 NCT01835587 Oct 2013 → Nov 2016 acute myeloid leukemia, myelodysplastic syndrome Celgene Corporation Completed No outcome recorded
Phase 210 trials · 3 missed
Phase 2 NCT05413018 Aug 2022 → Oct 2025 overdue acute myeloid leukemia Bristol-Myers Squibb Active not recruiting No outcome recorded
Phase 2 NCT04806906 Mar 2021 → Jan 2025 chronic myelomonocytic leukemia, myelodysplastic syndrome University of Florence Completed No outcome recorded
Phase 2 NCT04174196 Nov 2019 → Nov 2026 expected plasma cell myeloma, plasmacytoma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT03542266 Jun 2018 → Mar 2020 peripheral T-cell lymphoma, not otherwise specified Weill Medical College of Cornell University Completed No outcome recorded
Phase 2 NCT02494258 Oct 2015 → Apr 2025 hematopoietic and lymphoid cell neoplasm Celgene Corporation Completed No outcome recorded
Phase 2 NCT02546986 Oct 2015 → Apr 2017 non-small cell lung carcinoma Celgene Corporation Completed Missed primary
Phase 2 NCT02374099 Mar 2015 → Dec 2016 breast cancer Celgene Corporation Terminated Missed primary
Phase 2 NCT02269943 Feb 2015 → Apr 2017 nasopharyngeal neoplasm Celgene Corporation Completed No outcome recorded
Phase 2 NCT02250326 Jan 2015 → Jul 2017 non-small cell lung carcinoma Celgene Corporation Completed Missed primary
Phase 2 NCT01928576 Nov 2013 → Apr 2023 non-small cell lung carcinoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Comparator or background therapy3 trials
Phase 2 NCT04778410 Background Jun 2021 → Mar 2024 myeloid neoplasm Gilead Sciences Terminated No outcome recorded Stop: Business
Phase 2 NCT02900560 Comparator Dec 2016 → May 2021 ovarian epithelial tumor Translational Research in Oncology Terminated No outcome recorded
— NCT03723135 Background — acute myeloid leukemia Celgene Corporation Approved for marketing No outcome recorded

Press releases naming this drug 13 releases

DateIssuerRelease
2023-12-10 AbbVie ImmunoGen Presents Findings from Newly Diagnosed Acute Myeloid Leukemia Cohorts in Phase 1b/2 Study of Pivekimab Sunirine in Combination with Azacitidine and Venetoclax at ASH abbvie.com ↗
2023-07-21 Gilead Sciences Gilead To Discontinue Phase 3 ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS gilead.com ↗
2022-01-25 Gilead Sciences Gilead Announces Partial Clinical Hold for Studies Evaluating Magrolimab in Combination With Azacitidine gilead.com ↗
2021-06-18 Bristol-Myers Squibb Bristol Myers Squibb Receives European Commission Approval for Onureg® (azacitidine tablets) as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia bms.com ↗
2021-04-23 Bristol-Myers Squibb Bristol Myers Squibb Receives Positive CHMP Opinion for Onureg® (azacitidine tablets; CC-486) as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia in First Remission bms.com ↗
2020-12-07 Bristol-Myers Squibb Bristol Myers Squibb Presents Analyses from Pivotal QUAZAR® AML-001 Study of Onureg® (azacitidine tablets; CC-486) in Adults with Acute Myeloid Leukemia in First Remission bms.com ↗
2020-09-01 Bristol-Myers Squibb U.S. Food and Drug Administration Approves Onureg® (azacitidine tablets), a New Oral Therapy, as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia bms.com ↗
2020-06-13 AbbVie VENCLEXTA®/VENCLYXTO® (venetoclax) Plus Azacitidine Demonstrates Statistically Significant Overall Survival Benefit and Improved Remission Rates in Treatment-Naïve Acute Myeloid Leukemia Patients abbvie.com ↗
2020-05-29 Gilead Sciences Investigational Magrolimab in Combination With Azacitidine Demonstrates Durable Activity in Previously-Untreated Myelodysplastic Syndrome and Acute Myeloid Leukemia gilead.com ↗
2020-05-22 Bristol-Myers Squibb European Medicines Agency Validates Bristol Myers Squibb’s Applications for Idecabtagene Vicleucel (Ide-cel, bb2121) and CC-486 bms.com ↗
2020-05-01 Bristol-Myers Squibb U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia bms.com ↗
2020-03-23 AbbVie AbbVie Announces Positive Topline Results from Phase 3 Trial of VENCLEXTA® (venetoclax) in Combination with Azacitidine in Patients with Acute Myeloid Leukemia (AML) abbvie.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 20 sources stand behind the page.

FieldValueCited text
Known as CC-486 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02269943 ↗
18

NCT04887857 ↗

NCT02374099 ↗

NCT01928576 ↗

NCT04174196 ↗

NCT02494258 ↗

NCT04722601 ↗

NCT05413018 ↗

NCT01835587 ↗

NCT04639843 ↗

NCT01478685 ↗

Show 8 more sources

Known as 5-azacitidine “CC-486 (5-azacitidine) with a dose of 300mg oral intake daily will be given on day 1 to day 10 for 8 cycles.” NCT04639843 ↗
Known as azacitidine “This phase 2 study evaluated oral azacitidine (CC-486) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as initial treatment for PTCL.” PMID 36796016 ↗ May 2023
Known as Oral Azacitidine “The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486, known as oral azacitidine, in patients with AML or MDS after allogeneic hematopoetic...” NCT01835587 ↗
1

“Oral Azacitidine” NCT03723135 ↗

Route Oral “administered orally” NCT01478685 ↗