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Last Updated: September 26, 2021

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CLINICAL TRIALS PROFILE FOR ONUREG

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All Clinical Trials for Onureg

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04734990 ↗ Seclidemstat and Azacitidine for the Treatment of Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Not yet recruiting M.D. Anderson Cancer Center Phase 1/Phase 2 2021-06-30 This phase I/II trial identifies the best dose of seclidemstat when given together with azacitidine in treating patients with myelodysplastic syndrome or chronic myelomonocytic leukemia. Seclidemstat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine may help block the formation of growths that may become cancer. Giving seclidemstat and azacytidine may kill more cancer cells.
NCT04752163 ↗ DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Not yet recruiting M.D. Anderson Cancer Center Phase 1/Phase 2 2021-07-30 This phase I/II trial studies the effect of DS-1594b with or without azacitidine, venetoclax, or mini-HCVD in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has come back (recurrent) or not responded to treatment (refractory). Chemotherapy drugs, such as azacitidine, venetoclax, and mini-HCVD, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. DS-1594b may inhibit specific protein bindings that cause blood cancer. Giving DS-1594b, azacitidine, and venetoclax, or mini-HCVD may work better in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia.
NCT04778410 ↗ Study of Magrolimab Combinations in Participants With Myeloid Malignancies Not yet recruiting Gilead Sciences Phase 2 2021-03-01 The primary objectives of this study are to evaluate the safety, tolerability and to determine the recommended Phase 2 dose (RP2D) of magrolimab (Mag) in combination with the anti-leukemia therapies of venetoclax (Ven) and azacitidine (Aza) (Cohort 1), mitoxantrone, etoposide, and cytarabine (MEC) (Cohort 2) and CC-486 (Cohort 3) respectively in participants with acute myeloid leukemia (AML), to evaluate the efficacy of magrolimab in combination with the anti-leukemia therapies as determined by the rate of complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) (CR/CRi) (Phase 2 Cohorts 1 and 2) and to evaluate the efficacy of magrolimab in combination with anti-leukemia therapy CC-486 as determined by the minimal residual disease (MRD) negative response rate (Phase 2 Cohort 3).
NCT04887857 ↗ A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML) Not yet recruiting AbbVie Phase 1 2021-09-24 The Phase 1b, dose-finding parts of the study is to determine safety, tolerability, and preliminary efficacy of CC-486 (Onureg, oral azacitidine) in combination with venetoclax initially in the relapsed and/or refractory (R/R) AML participants who are ≥ 18 years of age, not eligible to receive further intensive therapy (Phase 1b, Part I); then in newly diagnosed AML participants who are ≥ 75 years of age, or ≥ 18 to 74 years of age with comorbidities that preclude the use of intensive induction chemotherapy or hematopoietic stem cell transplant (HSCT) (Phase 1b, Part II). Primary objective in Phase 1b is to establish maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) by evaluating safety and tolerability of CC-486 in combination with venetoclax. Key secondary objective is to assess the preliminary efficacy. Up to 4 dose levels of CC-486 with venetoclax may be explored. Once MTD is established in the R/R AML population, then safety and tolerability of this MTD will be evaluated in the newly diagnosed AML population. When MTD/RP2D is determined in the newly diagnosed AML population, then Phase 2 dose expansion part of the study will open for enrollment. Primary objective in Phase 2 is to assess efficacy of the RP2D of CC-486 and venetoclax in eligible newly diagnosed AML participants who are ≥ 75 years of age; or ≥ 18 to 74 years of age with comorbidities that preclude the use of intensive induction chemotherapy or HSCT. Key secondary objectives include evaluation of safety, overall response rate, time to response, duration of response, event-free survival, etc of this CC-486 and venetoclax combination in the frontline setting. This study is designed with the goal of developing CC-486 (oral azacitidine) as backbone for combination therapy to treat AML patients in the frontline setting.
NCT04887857 ↗ A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML) Not yet recruiting Celgene Phase 1 2021-09-24 The Phase 1b, dose-finding parts of the study is to determine safety, tolerability, and preliminary efficacy of CC-486 (Onureg, oral azacitidine) in combination with venetoclax initially in the relapsed and/or refractory (R/R) AML participants who are ≥ 18 years of age, not eligible to receive further intensive therapy (Phase 1b, Part I); then in newly diagnosed AML participants who are ≥ 75 years of age, or ≥ 18 to 74 years of age with comorbidities that preclude the use of intensive induction chemotherapy or hematopoietic stem cell transplant (HSCT) (Phase 1b, Part II). Primary objective in Phase 1b is to establish maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) by evaluating safety and tolerability of CC-486 in combination with venetoclax. Key secondary objective is to assess the preliminary efficacy. Up to 4 dose levels of CC-486 with venetoclax may be explored. Once MTD is established in the R/R AML population, then safety and tolerability of this MTD will be evaluated in the newly diagnosed AML population. When MTD/RP2D is determined in the newly diagnosed AML population, then Phase 2 dose expansion part of the study will open for enrollment. Primary objective in Phase 2 is to assess efficacy of the RP2D of CC-486 and venetoclax in eligible newly diagnosed AML participants who are ≥ 75 years of age; or ≥ 18 to 74 years of age with comorbidities that preclude the use of intensive induction chemotherapy or HSCT. Key secondary objectives include evaluation of safety, overall response rate, time to response, duration of response, event-free survival, etc of this CC-486 and venetoclax combination in the frontline setting. This study is designed with the goal of developing CC-486 (oral azacitidine) as backbone for combination therapy to treat AML patients in the frontline setting.
NCT04905810 ↗ Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure Not yet recruiting AbbVie Phase 2 2021-06-14 This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
NCT04905810 ↗ Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure Not yet recruiting National Cancer Institute (NCI) Phase 2 2021-06-14 This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Onureg

Condition Name

Condition Name for Onureg
Intervention Trials
Acute Myeloid Leukemia 2
Recurrent Myelodysplastic Syndrome 2
Recurrent Chronic Myelomonocytic Leukemia 2
Recurrent Acute Myeloid Leukemia 2
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Condition MeSH

Condition MeSH for Onureg
Intervention Trials
Leukemia 5
Leukemia, Myeloid, Acute 4
Leukemia, Myeloid 4
Leukemia, Myelomonocytic, Acute 2
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Clinical Trial Locations for Onureg

Trials by Country

Trials by Country for Onureg
Location Trials
United States 5
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Trials by US State

Trials by US State for Onureg
Location Trials
California 2
Texas 2
Oklahoma 1
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Clinical Trial Progress for Onureg

Clinical Trial Phase

Clinical Trial Phase for Onureg
Clinical Trial Phase Trials
Phase 2 2
Phase 1/Phase 2 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Onureg
Clinical Trial Phase Trials
Not yet recruiting 6
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Clinical Trial Sponsors for Onureg

Sponsor Name

Sponsor Name for Onureg
Sponsor Trials
M.D. Anderson Cancer Center 2
Brian Jonas 2
National Cancer Institute (NCI) 2
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Sponsor Type

Sponsor Type for Onureg
Sponsor Trials
Industry 5
Other 4
NIH 2
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