Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
AZD9291 and Simvastatin Interaction 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 days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in part a
Awards & highlights
Study Summary
This trial is a 2-part study of AZD9291, an EGFR mutation positive non-small cell lung cancer drug, to assess effect on the pharmacokinetic parameters of simvastatin and simvastatin acid.
Who is the study for?
This trial is for adults with EGFR mutation-positive NSCLC who've progressed after treatment with an EGFR tyrosine kinase inhibitor. They should have a life expectancy of at least 12 weeks, be in good physical condition (ECOG 0-1), and not have severe systemic diseases or active infections. Women must test negative for pregnancy or be non-child-bearing, and men agree to use condoms.Check my eligibility
What is being tested?
The study tests how the drug AZD9291 affects blood levels of Simvastatin in patients. Part A examines the interaction between these drugs, while Part B allows continued access to AZD9291 post-study until disease progression or lack of benefit. It's an open-label Phase I trial where all participants receive the same treatment.See study design
What are the potential side effects?
Potential side effects include those related to AZD9291 such as diarrhea, rash, dry skin, nail toxicity; and simvastatin-related like muscle pain, liver changes, and increased risk of diabetes. The study also monitors for any serious adverse reactions due to drug interactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ blood samples collected on days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in part a
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood samples collected on days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in part a
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC of Simvastatin
Cmax of Simvastatin
Secondary outcome measures
AUC of Simvastatin Acid
AUC(0-t) of Simvastatin and Simvastatin Acid
CL/F of Simvastatin
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: AZD9291 and simvastatinExperimental Treatment5 Interventions
Sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simvastatin
2012
Completed Phase 4
~1270
Pharmacokinetic sampling - AZD9291
2014
Completed Phase 1
~290
AZD9291 tablet dosing
2014
Completed Phase 1
~260
Pharmacokinetic sampling - AZ5140 and AZ7550
2014
Completed Phase 1
~290
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,289 Previous Clinical Trials
288,620,146 Total Patients Enrolled
Serban Ghiorghiu, MSDStudy DirectorAstraZeneca
5 Previous Clinical Trials
298 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung inflammation or damage that needed steroids.I am not taking medications that interact badly with simvastatin.My brain or spinal tumors are stable and I haven't needed steroids for 4 weeks.I have not consumed grapefruit or Seville oranges in the last 7 days.I don't have severe side effects from past treatments, except for hair loss or mild nerve pain from platinum-based therapy.I am not pregnant, using birth control, or cannot have children due to age or surgery.My cancer progressed despite treatment with an EGFR inhibitor.I do not have severe illnesses or infections that my doctor thinks would make it unsafe for me to join the study.My lung cancer diagnosis was confirmed through lab tests.My blood tests show I might not be healthy enough for this trial due to low blood counts or poor liver/kidney function.I am not allergic to AZD9291, simvastatin, or their ingredients.I cannot take pills by mouth or have GI issues affecting medication absorption.My tumor has an EGFR mutation sensitive to certain treatments.I haven't taken certain cancer drugs, had major surgery, or used specific supplements recently.I have heart issues or take medication that affects my heart's rhythm.My physical ability has been stable or better for the last 2 weeks.I have not had a bone marrow transplant or blood transfusion within the last 4 months.I am not taking cholesterol medications like lovastatin or simvastatin.I am 18 years old or older.I am a male willing to use condoms for 6 months after the last dose of the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: AZD9291 and simvastatin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger