Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Venetoclax

Azacitidine

Cc-486

Antimetabolites

Enzyme Inhibitors

CC-486

Bristol-Myers Squibb

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.

A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

AbbVie

Celgene

Single oral dose of Azacitidine 300 mg Film coated tablets

Single oral dose of Onureg® 300 mg Film Coated Tablets

Onureg

Ruba Jaber

A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions

Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)

A Randomized, Single Oral Dose, Open Label, Two Sequence, Two Treatment, Four Periods, Full Replicate Crossover Study to Determine the Bioequivalence of Azacitidine 300 mg Film- Coated Tablets Versus Onureg® 300 mg Film-Coated Tablets for Adult Patients With Acute Myeloid Leukaemia (AML) Under Fasting Conditions

Maximum measured plasma concentration over the time span specified

The area under the plasma concentration versus time curve, from time (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method.

The area under the plasma concentration versus time curve from time (0) to infinity.

Apparent first-order elimination or terminal rate constant

Time of the maximum measured plasma concentration.

Descriptive Change in clinical safety labs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)	NCT04887857	Leukemia, Myelo...	CC-486 Venetoclax	18 Years -	Celgene
Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)	NCT06326697	Acute Myeloid L...	Azacitidine Onureg	18 Years -	Hikma Pharmaceuticals LLC

Spots Global Cancer Trial Database for onureg

Every month we try and update this database with for onureg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for onureg

Every month we try and update this database with for onureg cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for onureg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.