AZD9291 for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lung Cancer+3 More
AZD9291 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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
  • Lung Cancer
  • Advanced (Inoperable) Non Small Cell Lung Cancer
  • Advanced Non Small Cell Lung Cancer (NSCLC)

Treatment Effectiveness

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: 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.

Day 10
AUC of AZ5104
AUC of AZ7550
AUC of AZD9291
AUC(0-120) of AZD9291
AUC(0-t) of AZD9291
CL/F of AZD9291
Cmax of AZ5104
Cmax of AZ7550
Cmax of AZD9291
Tmax of AZD9291
Vz/F of AZD9291
t1/2 of AZD9291

Trial Safety

Side Effects for

Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
100%Constipation
100%Diarrhoea
100%Dyspepsia
100%Vomiting
100%Myalgia
100%Rash
50%Hypokalaemia
50%Atrial fibrillation
50%Diverticulitis
50%Enterocolitis infectious
50%Anaemia
50%Mitral valve stenosis
50%Stomatitis
50%Chills
50%Dyspnoea
50%Pyrexia
50%Fatigue
50%Oedema peripheral
50%Dizziness
50%Headache
50%Thrombosis in device
50%Anxiety
50%Deep vein thrombosis
50%Hot flush
50%Hypertension
50%Hypotension
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT02179671) in the Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736 ARM group. Side effects include: Constipation with 100%, Diarrhoea with 100%, Dyspepsia with 100%, Vomiting with 100%, Myalgia with 100%.

Trial Design

1 Treatment Group

AZD9291 alone, AZD9291+itraconozole
1 of 1
Experimental Treatment

39 Total Participants · 1 Treatment Group

Primary Treatment: AZD9291 · No Placebo Group · Phase 1

AZD9291 alone, AZD9291+itraconozoleExperimental Group · 3 Interventions: AZD9291, Pharmacokinetic sampling, Itraconazole · Intervention Types: Drug, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved
Pharmacokinetic sampling
2014
Completed Phase 1
~260
Itraconazole
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,956 Previous Clinical Trials
91,808,822 Total Patients Enrolled
Serban Ghiorghiu, MSDStudy DirectorAstraZeneca
5 Previous Clinical Trials
311 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.