← Back to Search

Tyrosine Kinase Inhibitor

Bosutinib for Bladder Cancer

Phase 1
Waitlist Available
Led By Nagla Karim, MD
Research Sponsored by Nagla Abdel Karim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically or cytologically proven advanced, metastatic non-squamous non-small cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical cancer.
Measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 weeks
Awards & highlights

Study Summary

This trial will find the best dose of bosutinib to use with pemetrexed, and see if the combo is safe and has any effect on cancer.

Eligible Conditions
  • Bladder Cancer
  • Ovarian Cancer
  • Peritoneal Neoplasm
  • Thymic Cancer
  • Cervical Cancer
  • Thymoma
  • Non-Small Cell Lung Cancer
  • Mesothelioma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of dose escalation
This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of dose escalation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicity of the combination of bosutinib and pemetrexed
Pemetrexed
Secondary outcome measures
Adverse events of the combination of bosutinib and pemetrexed
Anti-tumor response rate
Progression-free survival

Side effects data

From 2020 Phase 3 trial • 536 Patients • NCT02130557
75%
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%
Lipase increased
21%
Fatigue
18%
Arthralgia
16%
Pyrexia
13%
Constipation
13%
Nasopharyngitis
13%
Asthenia
13%
Upper respiratory tract infection
12%
Back pain
12%
Neutropenia
11%
Decreased appetite
11%
Cough
11%
Dyspnoea
11%
Pruritus
10%
Dyspepsia
10%
Abdominal pain upper
10%
Urinary tract infection
10%
Pain in extremity
10%
Hypertension
9%
Influenza
9%
Amylase increased
9%
Dizziness
7%
Bronchitis
7%
Leukopenia
7%
Oedema peripheral
7%
Blood creatinine increased
7%
Dry skin
7%
Insomnia
6%
Sinusitis
6%
Blood alkaline phosphatase increased
6%
Blood bilirubin increased
6%
Oropharyngeal pain
6%
Alopecia
6%
Lymphopenia
6%
Influenza like illness
6%
Anxiety
5%
Abdominal distension
5%
Blood creatine phosphokinase increased
5%
Toothache
5%
Myalgia
5%
Rash maculo-papular
4%
Gastroenteritis
4%
Muscle spasms
3%
Gastrooesophageal reflux disease
3%
Hypophosphataemia
3%
Bone pain
3%
Pneumonia
3%
Weight increased
3%
Depression
3%
Face oedema
2%
Vision blurred
2%
Hypokalaemia
2%
Night sweats
1%
Pericarditis
1%
Hepatotoxicity
1%
Acute kidney injury
1%
Chronic kidney disease
1%
Hepatitis
1%
Cellulitis
1%
Coronary artery disease
1%
Femoral neck fracture
1%
Respiratory failure
1%
Myocardial ischaemia
1%
Atrial fibrillation
1%
Cholecystitis acute
1%
Musculoskeletal chest pain
1%
Rectal cancer
1%
Pregnancy of partner
1%
Hypertensive crisis
1%
Unintended pregnancy
1%
Haematuria
1%
Pleural effusion
1%
Cardiac failure acute
1%
Periorbital oedema
1%
Eyelid oedema
1%
Conjunctival haemorrhage
1%
Dry eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bosutinib
Imatinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bosutinib and PemetrexedExperimental Treatment2 Interventions
Bosutinib and pemetrexed
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bosutinib
2015
Completed Phase 3
~2390
Pemetrexed
2014
Completed Phase 3
~5250

Find a Location

Who is running the clinical trial?

Nagla Abdel KarimLead Sponsor
Nagla Karim, MDPrincipal InvestigatorAugusta University Georgia Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Mar 2025