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Endometroid Endometrial CancerPhase 2NCT05154487

A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

A Phase 2 study testing Alpelisib Pill and Fulvestrant injection in people with Endometroid Endometrial Cancer, run by GOG Foundation at 21 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid endometrial cancers by estimating the objective response rate (ORR). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometroid Endometrial Cancer
What is being tested?
Alpelisib Pill and Fulvestrant injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
21 sitesUnited States
Study dates
11 Sep 2024to 1 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have advanced (FIGO 2014 Stage III or IV), persistent, or recurrent endometrial carcinoma, which is not likely to be curable by surgery or radiotherapy. Histologic confirmation of recurrent disease is required. For cases of persistent disease, histologic confirmation of the primary disease with radiologic evidence of progression is required.
  • 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.
  • PIK3CA mutations considered oncogenic or likely oncogenic. i. Oncogenic/likely oncogenic PIK3CA mutations identified on tests performed by the labs listed on https://ecog-acrin.org/nci-match-eay131-designated-labs will be considered confirmed for the purposes of this study.
  • Oncogenic/likely oncogenic PIK3CA mutations identified by other tests will need to be confirmed by the study prior to enrollment.
  • Estrogen receptor (ER) status will be considered positive if ≥1% of tumor cells demonstrate positive nuclear staining by immunohistochemistry. Pathology report documenting ER status must be provided at enrollment.
  • Sites are required to report results of previous MMR and/or MSI status testing in the EDC if available.
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  • All patients must have measurable disease. Measurable disease is defined by RECIST version 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than or equal to 10mm when measured by CT, MRI or caliper measurement by clinical exam; or greater than or equal to 20mm when measured by chest x-ray. Lymph nodes must be greater than or equal to 15mm in short axis when measured by CT or MRI.
  • Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
  • Prior chemotherapy in the adjuvant setting for Stage I, II, or III or metastatic/recurrent/Stage IV is permitted. Prior chemoradiotherapy for a pelvic recurrence is permitted.
  • Prior immunotherapy and/or targeted therapy is allowed in addition to, in combination with, in lieu of, or subsequent to prior chemotherapy.
  • Prior hormone therapy (progesterone, tamoxifen, aromatase inhibitor) is allowed and not considered a prior line of therapy. Prior treatment with fulvestrant not allowed.
  • There are no limits on the number of prior lines of chemotherapy. Patients who received prior chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade less than or equal to 1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and initiation of therapy.
  • Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and initiation of therapy.
  • Patient must be able to swallow oral medications.
  • Patient must have an ECOG performance status of 0 to 2.
  • Patients must have adequate glucose control as defined by the following (both criteria must be met):
  • Fasting blood glucose (FBG) ≤140/dL (7.7mmol/L) AND
  • Hemoglobin A1c (HbA1c) ≤6.4%
  • Patients must have adequate organ and marrow function as defined below NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN
  • Bone marrow function:
  • Absolute neutrophil count (ANC) greater than or equal to 1000/mcl
  • Platelets greater than or equal to 100,000 cells/mcl
  • Hemoglobin greater than or equal to 8 g/dL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after erythrocyte transfusion).
  • Renal function:
  • Creatinine Clearance ≥ 35 mL/min using Cockcroft-Gault formula
  • Pancreatic function:
  • Fasting Serum amylase ≤ 2 × ULN
  • Fasting Serum lipase ≤ ULN
  • Hepatic function:
  • Bilirubin less than or equal to 1.5 x ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2 times ULN and direct bilirubin within normal limits are permitted).
  • ALT (alanine aminotransferase) and AST (aspartate aminotransferase) less than or equal to 3 x ULN
  • Albumin greater than or equal to 2.8 g/dL
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information.
  • Patients must be at least 18 years of age.
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing a highly effective form of contraception during the study treatment and for 8 weeks after stopping the treatment.
  • Highly effective contraception methods include combination of any of the following (NOTE: Estrogen containing contraceptives are prohibited):
  • Use of oral, injected, or implanted hormonal contraceptives or;
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS);
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;
  • Total abstinence or;
  • Male/female sterilization. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to registration. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.

Who cannot join

  • Patients who have previously received fulvestrant or any PIK3CA, PI3K, mTOR, or AKT inhibitor.
  • Patients with clear cell, serous, carcinosarcoma, mixed histology endometrial cancers, or uterine sarcomas.
  • Patients with known intolerance or hypersensitivity to alpelisib or fulvestrant, or any of their excipients.
  • Patient has had major surgery within 14 days prior to study treatment start and/or has not recovered from major side effects.
  • Patients with an established diagnosis of diabetes mellitus type I or uncontrolled type II (based on fasting blood glucose [FBG] and HemoglobinA1c [HbA1c], see inclusion criterion 67).
  • Patients with history of osteonecrosis of the jaw.
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  • Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.
  • Patients with active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection (such as known human immunodeficiency virus (HIV) positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]). Screening is not required for enrollment.
  • Patients with a serious pre-existing medical condition(s) that would preclude participation in this study (for example: interstitial lung disease or pneumonitis, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (i.e. estimated creatinine clearance <30ml/min), history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or pre-existing chronic condition resulting in baseline grade 2 or higher diarrhea).
  • Patients with a known history of cardiac disease. This includes:
  • Uncontrolled hypertension, defined as systolic greater than 150mm Hg or diastolic greater than 90mm Hg despite antihypertensive medications
  • Myocardial infarction, unstable angina, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to registration.
  • New York Heart Association (NYHA) Class II or greater congestive heart failure.
  • History of clinically significant cardiac arrhythmias (i.e. ventricular tachycardia or ventricular fibrillation, complete left bundle branch block, high grade AV block (e.g. bifascicular block, Mobitz type II and third degree AV block without pacemaker in place) or serious cardiac arrhythmia requiring medication. This does not include asymptomatic atrial fibrillation with controlled ventricular rate.
  • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or Fridericia QT correction formula (QTcF) > 470 msec at screening.
  • Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months prior to the first date of study therapy.
  • Syncope of cardiovascular etiology,
  • Sudden cardiac arrest.
  • Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of the treatment:
  • Strong CYP3A4 inducers
  • Inhibitors of BCRP.
  • Patients who are pregnant or breast-feeding.
  • Patients with known central nervous system metastases which was not previously treated and not fulfilling the following 3 criteria to be eligible for the study:
  • Completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of study entry and
  • CNS tumor is clinically stable at the time of screening and
  • Participant is not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases.
  • Patients with an impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study drugs (i.e. ulcerative disease; uncontrolled nausea, vomiting and/or diarrhea; malabsorption syndrome; clinical signs and symptoms of gastrointestinal obstruction; and/or patients who require parenteral hydration and/or nutrition).
  • Patients who plan to receive live attenuated vaccines within 1 week of start of alpelisib and during the study. Patients should also avoid close contact with others who have received live attenuated vaccines. Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG< yellow fever, varicella, and TY21a typhoid vaccines.
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder or coagulopathy.
  • Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days prior to dosing, or within 5 half-lives of the investigational product, whichever is longer.
  • Patient is not able to understand and to comply with study instructions and requirements, including oral administration of study treatment

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Johns Hopkins Medicine

    Baltimore, Maryland, 21287

  • City of Hope

    Duarte, California, 91010

  • Endeavor Health

    Evanston, Illinois, 60201

  • Endeavor Health Clinical Operations, Glenbrook Hospital

    Glenview, Illinois, 60026

  • Endeavor Health Clinical Operations, Highland Park Hospital

    Highland Park, Illinois, 60035

  • Ascension St. Vincent

    Indianapolis, Indiana, 46260

  • Kettering Health Cancer Center

    Kettering, Ohio, 45429

  • Northwell Health Cancer Institute

    Lake Success, New York, 11042

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • AdventHealth Gynecologic Oncology

    Orlando, Florida, 32804

  • Legacy Good Samaritan Medical Center

    Portland, Oregon, 97210

  • QCC- Northwell Health Physicians Partners Medical

    Rego Park, New York, 11374

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Moffit Cancer Center at International Plaza

    Tampa, Florida, 33607

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Legacy Meridian Park Medical Center

    Tualatin, Oregon, 97062

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

  • Legacy Salmon Creek Medical Center

    Vancouver, Washington, 98686

  • Moffit Cancer Center at Wesley Chapel

    Wesley Chapel, Florida, 33544

Other trials in United States

About this study

Official title: Phase 2 Study of Alpelisib and Fulvestrant for PIK3CA-mutated Estrogen Receptor (ER)-Positive Endometrioid Endometrial Cancers

This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid endometrial cancers by estimating the objective response rate (ORR). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.

Being tested
Alpelisib Pill, Fulvestrant injection
Keywords
advanced, persistent, recurrent, PIK3CA-mutated, ER-postive
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alpelisib PillDrug

    Also called Piqray

    Kinase inhibitor

  • Fulvestrant injectionDrug

    Also called Faslodex

    estrogen receptor agonist

Study groups in NCT05154487
Study groupRoleWhat they receive
Apelisib and FulvestrantExperimentalalpelisib 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.
Receives: Drug: Alpelisib Pill; Drug: Fulvestrant injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    To determine the objective response rate of the combination of alpelisib and fulvestrant in patients with advanced, persistent or recurrent PIK3CA-mutated ER-positive endometrioid endometrial cancer. Respnse criteria based on RECIST Version 1.1 (complete or partial response).

    Measured: 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.

Secondary outcomes (1)

  1. Drug Toxicity (Side Effects)

    Drug toxicity will be assessed by collecting adverse event data every 4 weeks

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start11 Sep 2024
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05154487
Sponsor's protocol ID
GOG-3069
Status last verified
Jul 2026
First submitted
23 Nov 2021
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alpelisib Pill and Fulvestrant injection in people with Endometroid Endometrial Cancer, run by GOG Foundation at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05154487.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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