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Oral Azacitidine for Blood Cancers

Phase 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Concomitant use of drugs that are prohibited.
Prior chemotherapy (including injectable azacitidine) or radiotherapy or any investigational agent after the last dose of oral azacitidine administered as part of the parent oral azacitidine study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a drug can help treat solid tumors and blood disorders.

Who is the study for?
This trial is for patients who have participated in previous CC-486 (oral azacitidine) studies for blood cancers and continue to meet those trials' criteria. They should benefit from ongoing treatment, adhere to the study's schedule, and use effective contraception if of childbearing potential.
What is being tested?
The study tests the long-term safety of CC-486 (oral azacitidine), a drug used for treating hematological disorders. It's a rollover study, meaning it continues treatment from previous trials with this medication.
What are the potential side effects?
While specific side effects are not listed here, oral azacitidine may include gastrointestinal symptoms like nausea or vomiting, low blood cell counts leading to increased infection risk or bleeding problems, and fatigue.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not taking any medications that are not allowed in the study.
Select...
I haven't had chemotherapy, radiotherapy, or experimental treatments after my last oral azacitidine dose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events (AEs)
Secondary study objectives
Overall Survival

Side effects data

From 2023 Phase 2 trial • 240 Patients • NCT02250326
57%
Nausea
53%
Vomiting
42%
Diarrhoea
41%
Constipation
34%
Decreased appetite
33%
Asthenia
32%
Alopecia
30%
Fatigue
24%
Peripheral sensory neuropathy
20%
Cough
20%
Dyspnoea
19%
Neutropenia
15%
Anaemia
15%
Oedema peripheral
14%
Arthralgia
13%
Pyrexia
13%
Paraesthesia
11%
Headache
11%
Weight decreased
11%
Myalgia
11%
Insomnia
10%
Stomatitis
10%
Dizziness
9%
Pulmonary embolism
9%
Abdominal pain
9%
Musculoskeletal pain
8%
Pleural effusion
8%
Dry skin
8%
Pain in extremity
6%
Neutrophil count decreased
6%
Dyspepsia
6%
Leukopenia
6%
Muscle spasms
6%
Pneumonia
6%
Nasopharyngitis
6%
Oral candidiasis
6%
Anxiety
5%
General physical health deterioration
5%
Haemorrhoids
5%
Back pain
5%
Vision blurred
5%
Haemoptysis
5%
Vertigo
5%
Muscular weakness
4%
Upper respiratory tract infection
4%
Productive cough
4%
Abdominal pain upper
4%
Non-cardiac chest pain
4%
Epistaxis
4%
Musculoskeletal chest pain
4%
Hypophosphataemia
3%
Pruritus
3%
Urinary tract infection
3%
Rhinorrhoea
3%
Pruritus generalised
3%
Hypomagnesaemia
3%
Alanine aminotransferase increased
3%
Performance status decreased
3%
Respiratory tract infection
3%
Bronchitis
3%
Hypotension
3%
Cancer pain
1%
Pneumonitis
1%
Hemiparesis
1%
Lower respiratory tract infection
1%
Hyponatraemia
1%
Paraparesis
1%
Abdominal wall abscess
1%
Blood glucose increased
1%
Generalised tonic-clonic seizure
1%
Intestinal obstruction
1%
Confusional state
1%
Acute kidney injury
1%
Haematuria
1%
Acute respiratory distress syndrome
1%
Interstitial lung disease
1%
Flushing
1%
Circulatory collapse
1%
Influenza
1%
Febrile neutropenia
1%
Metastases to meninges
1%
Flatulence
1%
Urinary tract obstruction
1%
Respiratory distress
1%
Pneumonia pneumococcal
1%
Sudden death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nab-Paclitaxel + CC-486
Nab-Paclitaxel + Durvalumab
Nab-Paclitaxel

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral Azacitidine (CC-486)Experimental Treatment1 Intervention
This study is an open-label, single-arm study and is divided into the screening period, treatment period and follow-up period. It is intended to evaluate the long-term safety of CC-486 and is to be taken at the same dose, schedule and frequency used from the last dose of CC-486 given in the parent study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-486
2015
Completed Phase 2
~670

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
130,453 Total Patients Enrolled
Barry Skikne, MD, FACP; FCPStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,572 Previous Clinical Trials
3,384,862 Total Patients Enrolled

Media Library

CC-486 Clinical Trial Eligibility Overview. Trial Name: NCT02494258 — Phase 2
Solid Tumors Research Study Groups: Oral Azacitidine (CC-486)
Solid Tumors Clinical Trial 2023: CC-486 Highlights & Side Effects. Trial Name: NCT02494258 — Phase 2
CC-486 2023 Treatment Timeline for Medical Study. Trial Name: NCT02494258 — Phase 2
~0 spots leftby Jan 2026
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