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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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 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 Simvastatin
Cmax of Simvastatin
Secondary outcome measures
AUC of Simvastatin Acid
AUC(0-t) of Simvastatin and Simvastatin Acid
CL/F of Simvastatin
+2 more

Trial 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
4,274 Previous Clinical Trials
288,613,312 Total Patients Enrolled
Serban Ghiorghiu, MSDStudy DirectorAstraZeneca
5 Previous Clinical Trials
298 Total Patients Enrolled

Media Library

AZD9291 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02197234 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: AZD9291 and simvastatin
Non-Small Cell Lung Cancer Clinical Trial 2023: AZD9291 Highlights & Side Effects. Trial Name: NCT02197234 — Phase 1
AZD9291 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02197234 — Phase 1

Frequently Asked Questions

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

How many individuals are eligible to participate in this trial?

"This research is no longer open for enrolment; the trial was initially posted on December 22nd 2014 and updated last August 31st 2022. If you are looking to participate in further studies, there are currently 1528 trials with openings for those diagnosed with non-small cell lung carcinoma (nsclc) as well as 137 clinical studies involving Simvastatin that still need patient recruitment."

Answered by AI

Is recruitment for this clinical trial currently accepting new participants?

"Per the information on clinicaltrials.gov, this particular medical trial is not accepting new participants; it was initially posted on December 22nd 2014 and most recently updated on August 31st 2022. However, there are 1,665 other trials that are actively searching for volunteers right now."

Answered by AI

Is this venture unprecedented in scope and nature?

"As of now, 137 ongoing clinical trials involving simvastatin have been launched across 57 nations and 1242 cities. Merck Sharp & Dohme LLC initiated the first such study in 2005; it enrolled 80 patients and reached Phase 4 drug approval stage. Subsequently, 332 further studies have finished since then."

Answered by AI

Am I eligible to be an experimental subject in this trial?

"A total of 52 patients, aged between 18 and 130 years old who have been diagnosed with non-small cell lung carcinoma (NSCLC), will be accepted into this trial. Additionally, male participants should comply to the use of barrier contraception until 6 months after they take their last dose while female candidates must provide evidence confirming that they are not in a childbearing period or utilize contraceptive measures if applicable. Furthermore, individuals should present an Eastern Cooperative Oncology Group performance standing at 0-1 without any decline over two weeks prior to enrollment as well as having a prognosis for life expectancy exceeding 12 weeks upon screening. Moreover, all applicants"

Answered by AI

Is the enrollment age of this clinical trial limited to individuals over fifty-five years old?

"As this trial requires that individuals are aged between 18 to 130, it is possible for those younger than 18 and older than 65 to apply. That said, there are 29 studies specifically targeting people under the age of eighteen while 1657 studies focus on adults over sixty-five years old."

Answered by AI

What therapeutic applications does Simvastatin typically serve?

"Malignant neoplasms can be managed with Simvastatin, and it also has efficacy for treating exercise-induced fatigue, peripheral vascular disease patient's symptoms, and diabetes mellitus."

Answered by AI

Does Simvastatin have official sanction from the FDA?

"The safety of Simvastatin is rated a 1 due to the fact that it has only just entered Phase 1 trials, meaning there are limited findings on its efficacy and security."

Answered by AI

What should be the anticipated outcome of this clinical experiment?

"The sponsor for this clinical trial, AstraZeneca, has identified AUC of Simvastatin as the primary outcome to be measured. Blood samples will be taken 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 time frame. Additionally they'll determine secondary outcomes including CL/F of Simvastatin (rate and extent of absorption), AUC of Simvastatin Acid (pharmacokinetics) and Cmax of Simvastatin Acid (maximum plasma concentration)."

Answered by AI

Has Simvastatin been tested as a treatment in other clinical trials?

"At this moment, 137 clinical trials are being conducted on Simvastatin. Among them, 24 have reached the Phase 3 testing stage. While most of these studies occur in Uniondale, New york, a total of 5169 locations around the world are running related tests for this medication."

Answered by AI
~5 spots leftby May 2025