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Anti-tumor antibiotic

Pharmacokinetic and Pharmacodynamic Assessment of Treatment With CPX-351 (Cytarabine: Daunorubicin) Liposome for Injection in Acute Leukemias and MDS Patients With Moderate Hepatic Impairment

Phase 2
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
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 pre-dose and up to day 21 during the first induction only, prior to every course the patient receives, early termination or end of study and 60 day post end of study.
Awards & highlights
No Placebo-Only Group

Summary

To assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics and their metabolites following administration of CPX-351.

Eligible Conditions
  • Leukemia
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and up to day 21 during the first induction only, prior to every course the patient receives, early termination or end of study and 60 day post end of study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and up to day 21 during the first induction only, prior to every course the patient receives, early termination or end of study and 60 day post end of study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total Drug Plasma PK
Secondary study objectives
Serum Copper Levels

Side effects data

From 2015 Phase 3 trial • 309 Patients • NCT01696084
68%
Febrile Neutropenia
49%
Nausea
46%
Diarrhoea
42%
Constipation
41%
Oedema Peripheral
35%
Headache
35%
Epistaxis
35%
Fatigue
33%
Cough
33%
Decreased Appetite
29%
Rash
27%
Chills
25%
Vomiting
24%
Dyspnoea
24%
Insomnia
22%
Abdominal Pain
22%
Pyrexia
21%
Dizziness
20%
Hypotension
20%
Hypoxia
19%
Hypertension
18%
Pneumonia
18%
Mucosal Inflammation
18%
Oropharyngeal Pain
17%
Pleural Effusion
16%
Arthralgia
15%
Pruritus
15%
Anxiety
14%
Tachycardia
14%
Petechiae
14%
Back Pain
13%
Confusional State
13%
Pain In Extremity
12%
Abdominal Distension
12%
Haemorrhoids
10%
Mouth Haemorrhage
9%
Rash Maculo-Papular
9%
Erythema
9%
Stomatitis
9%
Dyspepsia
9%
Asthenia
9%
Night Sweats
9%
Blood Blister
8%
Dysgeusia
8%
Fluid Overload
8%
Bacteraemia
8%
Transfusion Reaction
8%
Haemoptysis
8%
Sepsis
8%
Gingival Bleeding
8%
Oedema
8%
Procedural Pain
8%
Fall
8%
Neck Pain
8%
Pulmonary Oedema
8%
Rales
7%
Respiratory Failure
7%
Hyperhidrosis
7%
Wheezing
7%
Vision Blurred
7%
Dry Mouth
7%
Chest Pain
7%
Catheter Site Pain
7%
Musculoskeletal Pain
7%
Depression
7%
Renal Failure Acute
7%
Haematuria
7%
Rash Pruritic
6%
Ecchymosis
6%
Urinary Incontinence
6%
Abdominal Pain Upper
6%
Nasal Congestion
6%
Mouth Ulceration
6%
Ejection Fraction Decreased
6%
Dysphagia
6%
Catheter Site Erythema
6%
Cellulitis
6%
Contusion
5%
Pollakiuria
5%
Deep Vein Thrombosis
5%
Myalgia
5%
Dry Skin
5%
Hiccups
5%
Tachypnoea
5%
Dysuria
5%
Atrial Fibrillation
5%
Conjunctival Haemorrhage
5%
Chest Discomfort
5%
Agitation
4%
Acute Respiratory Failure
4%
Disease Progression
4%
Delirium
4%
Rash Erythematous
3%
Syncope
3%
Muscular Weakness
3%
Gastrooesophageal Reflux Disease
3%
Skin Lesion
3%
Oral Pain
3%
Hallucination
3%
Alopecia
3%
Weight Decreased
2%
Central Nervous System Haemorrhage
2%
Myocardial Infarction
2%
Somnolence
1%
Stenotrophomonas Test Positive
1%
Streptococcus Test Positive
1%
Mental Status Changes
1%
Haemorrhage Intracranial
1%
Cerebral Haemorrhage
1%
Fungal Test Positive
1%
Pancytopenia
1%
Euthyroid Sick Syndrome
1%
Hypothyroidism
1%
Urinary Tract Infection
1%
Enterococcus Test Positive
1%
Hepatic Enzyme Increased
1%
Neutropenia
1%
Pneumonia Bacterial
1%
Bacteroides Bacteraemia
1%
Streptococcal Sepsis
1%
Pseudomonas Test Positive
1%
Staphylococcus Test Positive
1%
Staphylococcal Bacteraemia
1%
Bronchopulmonary Aspergillosis
1%
Sinusitis Fungal
1%
Skin Infection
1%
Pneumonia Aspiration
1%
Pneumothorax
1%
Transfusion-Related Acute Lung Injury
1%
Alloimmunisation
1%
Anaemia
1%
Thrombocytopenia
1%
Cardiac Failure
1%
Cardiac Arrest
1%
Cardiac Failure Congestive
1%
Cardiomyopathy
1%
Mitral Valve Incompetence
1%
Pericarditis
1%
Small Intestinal Disorders
1%
Chron's Disease
1%
Gastric Haemorrhage
1%
Lower Gastrointestinal Haemorrhage
1%
Multi-Organ Failure
1%
Death
1%
Non-Cardiac Chest Pain
1%
Cholecystitis Acute
1%
Bile Duct Stone
1%
Septic Shock
1%
Enterococcal Bacteraemia
1%
Diverticulitis
1%
Enterobacter Bacteraemia
1%
Mycotic Aneurysm
1%
Neutropenic Infection
1%
Pseudomonal Bacteraemia
1%
Sinusitis
1%
Dehydration
1%
Lactic Acidosis
1%
Acute Myeloid Leukaemia
1%
Acute Myeloid Leukaemia Recurrent
1%
Myelodysplastic Syndrome
1%
Renal Cell Carcinoma
1%
Carotid Artery Stenosis
1%
Cerebral Infarction
1%
Convulsion
1%
Presyncope
1%
Radiculopathy
1%
Acute Respiratory Distress Syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (CPX-351)
Arm B (7+3)

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: CPX-351Experimental Treatment1 Intervention
Study Drug CPX-351 will be given intravenously at 100u/m2 on days 1, 3 and 5 by approximately 90 minute infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPX-351
2022
Completed Phase 3
~1170

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
250 Previous Clinical Trials
35,004 Total Patients Enrolled
Clinical Trial TransparencyStudy DirectorJazz Pharmaceuticals
~0 spots leftby Dec 2025
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