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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events (AEs)
Secondary outcome measures
Overall Survival
Side effects data
From 2023 Phase 2 trial • 240 Patients • NCT0225032657%
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%
Muscle spasms
6%
Neutrophil count decreased
6%
Leukopenia
6%
Dyspepsia
6%
Pneumonia
6%
Nasopharyngitis
6%
Oral candidiasis
6%
Anxiety
5%
Haemorrhoids
5%
Back pain
5%
General physical health deterioration
5%
Vision blurred
5%
Haemoptysis
5%
Vertigo
5%
Muscular weakness
4%
Productive cough
4%
Upper respiratory tract infection
4%
Abdominal pain upper
4%
Non-cardiac chest pain
4%
Epistaxis
4%
Musculoskeletal chest pain
4%
Hypophosphataemia
3%
Urinary tract infection
3%
Rhinorrhoea
3%
Hypomagnesaemia
3%
Alanine aminotransferase increased
3%
Performance status decreased
3%
Respiratory tract infection
3%
Bronchitis
3%
Hypotension
3%
Cancer pain
1%
Lower respiratory tract infection
1%
Abdominal wall abscess
1%
Hemiparesis
1%
Generalised tonic-clonic seizure
1%
Blood glucose increased
1%
Hyponatraemia
1%
Paraparesis
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 Combination Arm
Nab-Paclitaxel + Durvalumab Combination Arm
Nab-Paclitaxel Monotherapy Arm
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
~630
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,967 Total Patients Enrolled
Barry Skikne, MD, FACP; FCPStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,493 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can have children and meet specific health conditions.I am not taking any medications that are not allowed in the study.I haven't had chemotherapy, radiotherapy, or experimental treatments after my last oral azacitidine dose.I am currently taking oral azacitidine alone after participating in a study with it and another drug.My doctor thinks I am doing well on oral azacitidine and should continue it.I have been part of an oral azacitidine trial and still meet its requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Azacitidine (CC-486)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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