← Back to Search

EGFR TKI

Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
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 blood samples collected on day 1 and day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post azd9291 dose in part a.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if an antifungal medication, itraconazole, affects the effectiveness of a lung cancer drug, AZD9291, in patients whose cancer has not responded to standard treatments. Itraconazole has been studied for its potential anticancer effects.

Eligible Conditions
  • Lung Cancer
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood samples collected on day 1 and day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post azd9291 dose in part a.
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples collected on day 1 and day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post azd9291 dose in part a. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC of AZD9291
Cmax of AZD9291
Secondary study objectives
AUC of AZ5104
AUC of AZ7550
AUC(0-120) of AZD9291
+7 more

Side effects data

From 2023 Phase 3 trial • 29 Patients • NCT02454933
47%
Diarrhoea
41%
Paronychia
41%
Dermatitis acneiform
29%
Stomatitis
29%
Arthralgia
24%
Viral upper respiratory tract infection
24%
Cough
24%
Neutropenia
24%
Dyspnoea
24%
Pruritus
18%
Back pain
18%
Productive cough
18%
Rhinorrhoea
18%
Nausea
18%
Upper respiratory tract infection
18%
Neutrophil count decreased
18%
Dry skin
18%
Constipation
18%
Pneumonia
12%
Electrocardiogram QT prolonged
12%
Aspartate aminotransferase increased
12%
Vomiting
12%
Lung infection
12%
Musculoskeletal chest pain
12%
Alanine aminotransferase increased
12%
Decreased appetite
12%
Dizziness
12%
Dysphonia
12%
Epistaxis
12%
Rash maculo-papular
6%
Osteoporosis
6%
Colorectal cancer
6%
Tinnitus
6%
Flatulence
6%
Epigastric discomfort
6%
Hypertension
6%
Orthostatic hypotension
6%
Anaemia
6%
Spontaneous haemorrhage
6%
Ear discomfort
6%
Blepharitis
6%
Ocular hyperaemia
6%
Hypoacusis
6%
Blepharospasm
6%
Mouth ulceration
6%
Fatigue
6%
Gastritis
6%
Asthenia
6%
Catheter site injury
6%
Complication associated with device
6%
Gastroenteritis
6%
Ligament sprain
6%
Joint swelling
6%
Muscle spasms
6%
Osteoarthritis
6%
Headache
6%
Hypoaesthesia
6%
Anxiety
6%
Insomnia
6%
Renal vein embolism
6%
Urinary incontinence
6%
Milia
6%
Uterine mass
6%
Laryngeal haemorrhage
6%
Organising pneumonia
6%
Sinus congestion
6%
Onychoclasis
6%
Pain of skin
6%
Pruritus generalised
6%
Rash macular
6%
Hot flush
6%
Dry eye
6%
Eyelid pain
6%
Retinal drusen
6%
Abdominal pain
6%
Oesophageal pain
6%
Toothache
6%
Pain
6%
Seasonal allergy
6%
Atypical pneumonia
6%
Cystitis
6%
Influenza
6%
Lower respiratory tract infection
6%
Oral candidiasis
6%
Sinusitis
6%
Avulsion fracture
6%
Fall
6%
Urine analysis abnormal
6%
Bone pain
6%
Musculoskeletal pain
6%
Pain in extremity
6%
Amnesia
6%
Paraesthesia
6%
Vaginal haemorrhage
6%
Nasal congestion
6%
Pleural effusion
6%
Sneezing
6%
Eczema asteatotic
6%
Intertrigo
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Rash
6%
Skin fissures
6%
Urticaria
6%
Xanthelasma
6%
Urinary tract infection
6%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Osimertinib 80 mg
Osimertinib 80 mg + Durvalumab 10 mg/kg

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: AZD9291 alone, AZD9291+itraconozoleExperimental Treatment3 Interventions
Sequential treatments of AZD9291 alone followed by AZD9291+itraconazole, with a washout period in between.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD9291
2014
Completed Phase 3
~1100
Pharmacokinetic sampling
2014
Completed Phase 1
~300
Itraconazole
2017
Completed Phase 2
~830

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,123,554 Total Patients Enrolled
Serban Ghiorghiu, MSDStudy DirectorAstraZeneca
5 Previous Clinical Trials
311 Total Patients Enrolled
~4 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top