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Tyrosine Kinase Inhibitor
Bosutinib In Subjects With Renal Impairment
Phase 1
Waitlist Available
Research Sponsored by Pfizer
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
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal impairment and subjects with normal renal function will be enrolled. Subjects with mild and moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1 suggest a substantial difference in PK profiles between subjects with severe renal impairment and subjects with normal renal function.
Eligible Conditions
- Kidney Failure
- Chronic Kidney Disease
- Acute Kidney Injury
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
Side effects data
From 2020 Phase 3 trial • 536 Patients • NCT0213055775%
Diarrhoea
37%
Nausea
36%
Thrombocytopenia
34%
Alanine aminotransferase increased
26%
Aspartate aminotransferase increased
23%
Abdominal pain
23%
Rash
22%
Anaemia
22%
Headache
21%
Vomiting
21%
Fatigue
21%
Lipase increased
18%
Arthralgia
16%
Pyrexia
13%
Constipation
13%
Asthenia
13%
Upper respiratory tract infection
13%
Nasopharyngitis
12%
Neutropenia
12%
Back pain
11%
Decreased appetite
11%
Cough
11%
Dyspnoea
11%
Pruritus
10%
Hypertension
10%
Abdominal pain upper
10%
Dyspepsia
10%
Urinary tract infection
10%
Pain in extremity
9%
Influenza
9%
Amylase increased
9%
Dizziness
7%
Leukopenia
7%
Oedema peripheral
7%
Bronchitis
7%
Blood creatinine increased
7%
Insomnia
7%
Dry skin
6%
Lymphopenia
6%
Influenza like illness
6%
Sinusitis
6%
Blood alkaline phosphatase increased
6%
Blood bilirubin increased
6%
Anxiety
6%
Oropharyngeal pain
6%
Alopecia
5%
Abdominal distension
5%
Toothache
5%
Blood creatine phosphokinase increased
5%
Myalgia
5%
Rash maculo-papular
4%
Gastroenteritis
4%
Muscle spasms
3%
Pneumonia
3%
Gastrooesophageal reflux disease
3%
Face oedema
3%
Weight increased
3%
Hypophosphataemia
3%
Bone pain
3%
Depression
2%
Vision blurred
2%
Hypokalaemia
2%
Night sweats
1%
Cholecystitis acute
1%
Myocardial ischaemia
1%
Atrial fibrillation
1%
Cardiac failure acute
1%
Coronary artery disease
1%
Pericarditis
1%
Hepatitis
1%
Hepatotoxicity
1%
Cellulitis
1%
Femoral neck fracture
1%
Musculoskeletal chest pain
1%
Rectal cancer
1%
Unintended pregnancy
1%
Acute kidney injury
1%
Chronic kidney disease
1%
Haematuria
1%
Pleural effusion
1%
Respiratory failure
1%
Pregnancy of partner
1%
Hypertensive crisis
1%
Periorbital oedema
1%
Eyelid oedema
1%
Conjunctival haemorrhage
1%
Dry eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bosutinib
Imatinib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Severe Renal ImpairmentExperimental Treatment1 Intervention
Group II: Moderate Renal ImpairmentExperimental Treatment1 Intervention
Group III: Mild Renal ImpairmentExperimental Treatment1 Intervention
Group IV: Healthy VolunteersExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bosutinib
FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,147 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,758,003 Total Patients Enrolled