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PI3K Inhibitor
Alpelisib + Fulvestrant for Endometrial Cancer
Phase 2
Recruiting
Research Sponsored by GOG Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Negative serum pregnancy test and practicing highly effective contraception for patients of childbearing potential
Patients must have endometrioid histology (all grades allowed) based on hysterectomy or biopsy specimen and have positive expression of ER and oncogenic PIK3CA mutation per criteria below.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up side effects are monitor from the start of treatment to discontinuation of treatment assessed every 4 weeks. patients are treated until disease progression and are followed for 5 years.
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat endometrial cancers that have a specific genetic mutation. The goal is to find out if the combination can shrink tumors.
Who is the study for?
This trial is for adults with recurrent or primary endometrioid endometrial cancer that's ER-positive and PIK3CA-mutated. Participants must have measurable disease, be recovered from prior treatments, have good performance status (ECOG 0-1), controlled blood sugar levels, and adequate organ function. They can't have had certain previous inhibitors, other cancer types or treatments, uncontrolled diabetes type II, serious infections or conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial tests a combination of an alpelisib pill and fulvestrant injection in patients to see how well it works against specific mutations in endometrial cancer. The main goal is to measure the objective response rate (ORR) - basically how many patients see their tumors shrink or disappear after treatment.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site for fulvestrant, high blood sugar levels due to alpelisib which may require monitoring and management of diet or medication adjustments. Other common issues might involve digestive problems like nausea or diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and use effective birth control.
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My endometrial cancer is ER positive and has a PIK3CA mutation.
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I have recovered from the major side effects of my cancer treatments.
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My endometrial cancer is advanced, persistent, or recurrent and cannot be cured by surgery or radiotherapy.
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I have at least one tumor that can be measured with scans or exams.
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I have had only one chemotherapy treatment before.
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My endometrial cancer is advanced, persistent, or recurrent and cannot be cured by surgery or radiotherapy.
Select...
My cancer has come back or gotten worse, confirmed by tests.
Select...
My cancer is endometrioid with positive estrogen receptors and a PIK3CA mutation.
Select...
I am fully active or can carry out light work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ response to treatment is assessed by recist version 1.1 criteria every 8 weeks with ct scan or mri through completion of treatment (complete or partial response). patients receive treatment until disease progression and are followed for 5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~response to treatment is assessed by recist version 1.1 criteria every 8 weeks with ct scan or mri through completion of treatment (complete or partial response). patients receive treatment until disease progression and are followed for 5 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
Drug Toxicity (Side Effects)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Apelisib and FulvestrantExperimental Treatment2 Interventions
alpelisib 300mg orally daily of each 28-day cycle fulvestrant 500mg IM on Day 1 and Day 15 of Cycle 1, then 500mg IM on Day 1 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant injection
2023
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
GOG FoundationLead Sponsor
42 Previous Clinical Trials
16,690 Total Patients Enrolled
4 Trials studying Endometrial Cancer
1,498 Patients Enrolled for Endometrial Cancer
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,984 Total Patients Enrolled
4 Trials studying Endometrial Cancer
114 Patients Enrolled for Endometrial Cancer
Stephanie Gaillard, MDStudy ChairGOG Foundation
3 Previous Clinical Trials
83 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and use effective birth control.I currently have an active infection.I've had chemotherapy for early-stage cancer or for a pelvic recurrence.My endometrial cancer is ER positive and has a PIK3CA mutation.I am currently experiencing active bleeding or have a condition that greatly increases my risk of bleeding.I have recovered from the major side effects of my cancer treatments.You are either pregnant or currently breastfeeding.I have a digestive issue that affects how my body absorbs medication.My cancer is one of the specified types affecting the uterus.The study site needs to provide any previous results of MMR and/or MSI testing in a specific database called Medidata Rave.I do not plan to get any live vaccines within a week of starting alpelisib or during the study.My cancer has a specific PIK3CA mutation listed or one recognized later as oncogenic.I have at least one measurable tumor to track treatment progress.I haven't had chemotherapy for Stage IV disease unless I was disease-free after it and had 6+ months without cancer worsening.My brain metastases do not meet the study's requirements.I haven't taken part in a drug trial within the last 30 days or 5 half-lives of the drug.I have at least one tumor that can be measured with scans or exams.My endometrial cancer is advanced, persistent, or recurrent and cannot be cured by surgery or radiotherapy.1. You have a specific genetic mutation called PIK3CA that has been confirmed by certain labs listed on a website.
2. If your PIK3CA mutation was identified by a different lab, it will need to be confirmed by the study before you can participate.
3. You must have a positive result for estrogen receptor status, which means at least 1% of your tumor cells show a certain type of staining when tested. You will need to provide a pathology report that shows your estrogen receptor status before you can enroll in the study.I have had only one chemotherapy treatment before.I've had chemotherapy or chemoradiotherapy for early-stage cancer or a pelvic recurrence.I can take pills by mouth.My endometrial cancer is advanced, persistent, or recurrent and cannot be cured by surgery or radiotherapy.My cancer has come back or gotten worse, confirmed by tests.My cancer is endometrioid with positive estrogen receptors and a PIK3CA mutation.It has been over 21 days since my last chemotherapy treatment.I am fully active or can carry out light work.My organs and bone marrow are working well.I am 18 years old or older.I have taken drugs targeting PIK3CA, PI3K, mTOR, or AKT before.I have had hormonal therapy for endometrial cancer.I haven't had major surgery or recovered from its major side effects within the last 14 days.I have type 1 diabetes or my type 2 diabetes is not under control.I do not have serious health issues that would stop me from joining this study.I am on medication that cannot be stopped a week before starting the treatment.I understand and can follow the study's instructions and requirements.It has been more than 14 days since my last radiotherapy session.You are allergic or have an adverse reaction to alpelisib or fulvestrant, or any of their ingredients.I have not had any other cancer besides this one in the last 5 years.I have a known heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Apelisib and Fulvestrant
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is Alpelisib Pill used to treat most frequently?
"Alpelisib Pills are frequently used to treat endocrine-resistant cancers, as well as other conditions like breast cancer and Pik3ca gene mutations."
Answered by AI
Are patients able to sign up for this experimental treatment option at this time?
"The clinical trial in question is not currently looking for patients, as the most recent update on September 1st, 2022 indicates. However, there are 453 other studies that are presently enrolling participants."
Answered by AI
Are there other scientific studies that have utilized Alpelisib Pill?
"There are a total of 159 clinical studies underway that are researching Alpelisib Pill. Out of those, 36 trials are currently in Phase 3. Many of the studies for Alpelisib Pill originate from Shanghai, China; however, there are 6520 locations around the world where research is being conducted for this treatment."
Answered by AI
Has Alpelisib been cleared for public consumption by the FDA?
"While there is some clinical data supporting the safety of Alpelisib Pill, it did not yet receive a score of 3 because efficacy has not been proven."
Answered by AI
How many people will be included in this clinical research project at most?
"This study is not looking for patients at the moment, as the last update was on September 1st, 2022. It was originally posted January 1st, 2023. For other studies, there are 294 clinical trials actively recruiting patients with endometroid endometrial cancer and 159 studies for Alpelisib Pill actively looking for patients."
Answered by AI
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