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AZD9291 and Simvastatin Interaction for Non-Small Cell Lung Cancer
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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: AZD9291 and simvastatin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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"
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."
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."
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."
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)."
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."
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