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EGFR TKI

AZD9291 for Non-Small Cell Lung Cancer

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

Study Summary

This trial is testing a new drug to see if it's effective in treating lung cancer that has progressed despite other treatments. The trial will assess the drug's effect on the cancer, as well as the drug's safety and side effects.

Eligible Conditions
  • 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC of AZD9291
Cmax of AZD9291
Secondary outcome measures
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%
Rhinorrhoea
18%
Back pain
18%
Productive cough
18%
Nausea
18%
Upper respiratory tract infection
18%
Neutrophil count decreased
18%
Dry skin
18%
Constipation
18%
Pneumonia
12%
Musculoskeletal chest pain
12%
Electrocardiogram QT prolonged
12%
Lung infection
12%
Aspartate aminotransferase increased
12%
Vomiting
12%
Alanine aminotransferase increased
12%
Decreased appetite
12%
Dizziness
12%
Dysphonia
12%
Epistaxis
12%
Rash maculo-papular
6%
Joint swelling
6%
Orthostatic hypotension
6%
Fatigue
6%
Blepharospasm
6%
Blepharitis
6%
Catheter site injury
6%
Tinnitus
6%
Hypoaesthesia
6%
Pain of skin
6%
Insomnia
6%
Hypoacusis
6%
Spontaneous haemorrhage
6%
Ear discomfort
6%
Gastroenteritis
6%
Sinus congestion
6%
Complication associated with device
6%
Asthenia
6%
Hypertension
6%
Anxiety
6%
Anaemia
6%
Onychoclasis
6%
Headache
6%
Ocular hyperaemia
6%
Epigastric discomfort
6%
Gastritis
6%
Mouth ulceration
6%
Ligament sprain
6%
Muscle spasms
6%
Osteoarthritis
6%
Renal vein embolism
6%
Urinary incontinence
6%
Uterine mass
6%
Laryngeal haemorrhage
6%
Rash macular
6%
Organising pneumonia
6%
Hot flush
6%
Dry eye
6%
Eyelid pain
6%
Retinal drusen
6%
Abdominal pain
6%
Flatulence
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%
Osteoporosis
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%
Milia
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Pruritus generalised
6%
Rash
6%
Skin fissures
6%
Urticaria
6%
Xanthelasma
6%
Urinary tract infection
6%
Pyrexia
6%
Colorectal cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Osimertinib 80 mg
Osimertinib 80 mg + Durvalumab 10 mg/kg

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
~780

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,256 Previous Clinical Trials
288,593,597 Total Patients Enrolled
Serban Ghiorghiu, MSDStudy DirectorAstraZeneca
5 Previous Clinical Trials
311 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objective is this experiment attempting to accomplish?

"The primary goal of the clinical trial is to measure and analyse the area under concentration curve (AUC) of AZD9291. Secondary objectives include determining the terminal half-life, volume distribution, and maximum plasma concentration of its metabolite AZ5104. This data will be collected from blood samples taken at pre-dose on Day 1 and 10 as well as post-dose hours 1, 2, 3, 4, 6 8 etc up to 216 in Part A."

Answered by AI

Does this research study involve any innovative techniques?

"Currently, there are 114 active research trials for AZD9291 which span 51 countries and 1073 cities. This drug's inception occurred in 2013 when AstraZeneca ran a Phase 1 & 2 approval study involving 603 patients; since then, 250 studies have already been concluded."

Answered by AI

Is this experiment recruiting participants at the present moment?

"This study is not currently enrolling interested individuals. It was first posted in November 2014 and last edited September 2022. However, there are 1912 open clinical trials related to lung cancer and 114 taking AZD9291 that are accepting volunteers at this moment."

Answered by AI

Does my profile meet the criteria for enrollment in this clinical trial?

"Eligibility criteria for this medical trial necessitates participants have a diagnosis of lung cancer, and be between 18 to 99 years old. Currently, 39 individuals are being sought out to participate in the study."

Answered by AI

What pathologies is AZD9291 employed in remedying?

"AZD9291 is typically used to treat chromomycosis, vulvovaginal candidiasis, disseminated other specified protozoal diseases and dermatomycoses."

Answered by AI

Are seniors aged 75 and over eligible for enrollment in this experiment?

"This trial seeks individuals aged 18 to 99 years old. There are 44 studies for patients under the legal age of consent and 2018 studies specifically designated for seniors over 65."

Answered by AI

To what extent is enrollment open for this research study?

"Unfortunately, this research study is no longer recruiting participants. Posting for the trial began on November 6th 2014 and was last updated September 15th 2022. However, there are 1,912 active studies to treat lung cancer as well as 114 trials that involve AZD9291 actively looking for patients currently."

Answered by AI

Has the Food and Drug Administration sanctioned AZD9291 for use?

"The safety rating for AZD9291 is a 1, as it remains in Phase 1 trials which lack substantial evidence of its efficacy and security."

Answered by AI

Is there prior evidence of AZD9291 efficacy through research studies?

"AZD9291 was first tested in 2013 at Research Site. Since then, 250 trials have been carried out with promising results. Currently, 114 active studies are underway throughout the country but particularly concentrated in San Diego, California."

Answered by AI
Recent research and studies
British Journal of Clinical PharmacologyJournal
The Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Osimertinib
Vishwanathan, Karthick, Paul A. Dickinson, Karen So, Karen Thomas, Yuh-Min Chen, Javier De Castro Carpeño, Anne-Marie C. Dingemans, et al.. 2018. “The Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Osimertinib”. British Journal of Clinical Pharmacology. Wiley. doi:10.1111/bcp.13534.
clinicaltrials.govStudy
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)
2014. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02157883.
~4 spots leftby Apr 2025
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