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AKT Inhibitor
Drug Combinations for Endometrial Cancer
Phase 2
Waitlist Available
Led By Helen J Mackay
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequately controlled thyroid function, with no symptoms of thyroid dysfunction
Patients must have evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or non-measurable (detectable) disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying four different combinations of drugs as treatments for endometrial cancer.
Who is the study for?
This trial is for women with certain types of recurrent or refractory endometrial cancer. Participants must have adequate organ function, controlled blood pressure, and no severe allergies to the drugs being tested. They should not be pregnant, must agree to use contraception, and cannot have had certain prior treatments or serious health conditions like bowel obstruction or heart issues.Check my eligibility
What is being tested?
The study tests combinations of olaparib with durvalumab, cediranib with durvalumab, olaparib with capivasertib, and cediranib alone in patients whose endometrial cancer has returned or resisted treatment. These drugs aim to block tumor growth by targeting enzymes needed for cell growth or interfering with tumor cells' ability to spread.See study design
What are the potential side effects?
Potential side effects include fatigue; nausea; diarrhea; high blood pressure; allergic reactions such as rashes; anemia (low red blood cell counts); neutropenia (low white blood cell counts), which can increase infection risk; liver enzyme changes suggesting liver injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My thyroid function is normal, with no symptoms of issues.
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My cancer can be measured by standard criteria or is detectable.
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I have received one chemotherapy treatment for endometrial cancer, which may have included radiation.
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My endometrial cancer has come back or hasn't responded to treatment, and it's not clear cell type.
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My body weight is over 30 kg.
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I am 18 years old or older.
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My kidney function, measured by creatinine clearance, is good.
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I am postmenopausal or cannot become pregnant, confirmed by a recent test.
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I can swallow pills and don't have stomach issues affecting medicine absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Incidence of adverse events
Objective tumor response
Overall survival
Other outcome measures
Markers of angiogenesis in serial plasma samples
Mutations in deoxyribonucleic acid (DNA) Homologous Repair Genes
Trial Design
6Treatment groups
Experimental Treatment
Group I: Arm VI (cediranib maleate, durvalumab)Experimental Treatment8 Interventions
Patients receive cediranib maleate PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
Group II: Arm V (olaparib, durvalumab)Experimental Treatment8 Interventions
Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
Group III: Arm IV (olaparib, capivasertib)Experimental Treatment8 Interventions
Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
Group IV: Arm III (cediranib maleate, olaparib)Experimental Treatment9 Interventions
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
Group V: Arm II (olaparib)Experimental Treatment7 Interventions
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
Group VI: Arm I (cediranib maleate)Experimental Treatment8 Interventions
Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11670
Computed Tomography
2017
Completed Phase 2
~2720
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Biospecimen Collection
2004
Completed Phase 2
~1730
Capivasertib
2021
Completed Phase 1
~130
Cediranib
2016
Completed Phase 3
~4030
Cediranib Maleate
2010
Completed Phase 2
~660
Durvalumab
2017
Completed Phase 2
~3870
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,379 Total Patients Enrolled
18 Trials studying Endometrial Carcinoma
8,838 Patients Enrolled for Endometrial Carcinoma
NRG OncologyOTHER
231 Previous Clinical Trials
100,564 Total Patients Enrolled
3 Trials studying Endometrial Carcinoma
223 Patients Enrolled for Endometrial Carcinoma
Helen J MackayPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your white blood cell count is higher than 1.5 x 10^9/L within the last 28 days.I have not been in trials for specific cancer drugs before, except for bevacizumab or single-agent immune therapy.I have had Bevacizumab or one immune-checkpoint therapy, but not durvalumab, before joining this trial.My thyroid function is normal, with no symptoms of issues.My cancer can be measured by standard criteria or is detectable.I have received one chemotherapy treatment for endometrial cancer, which may have included radiation.Your bilirubin level in the blood is not more than 1.5 times the upper limit of normal.You have had certain types of cancer within the last 5 years, ongoing severe side effects from previous cancer treatments, or a history of serious allergic reactions to specific medications.I have controlled colitis or chronic diarrhea, and haven't needed steroids for colitis.I haven't had cancer treatment or been in a trial in the last 4 weeks.I am not currently using strong or moderate drugs that affect liver enzymes.I have not had a stroke or a mini-stroke in the last 6 months.You have had a heart attack or unstable angina within the past 6 months, abnormal ECG findings, severe heart disease, a recent major surgery, or an abdominal abscess within the past 3 months.I have not had a whole blood transfusion in the last 4 months.Your urine test shows a small amount of protein, or the ratio of protein to creatinine in your urine is less than 1.I am using two reliable birth control methods during and 4 weeks after the study.I have had one non-chemotherapy treatment for my cancer, but not with specific excluded drugs.I am not using any herbal or alternative medicines.I am not on strong immune system suppressing drugs, except for certain allowed cases.My endometrial cancer has come back or hasn't responded to treatment, and it's not clear cell type.My body weight is over 30 kg.I am 18 years old or older.I am a woman agreeing to use birth control and have a negative pregnancy test before the study.My kidney function, measured by creatinine clearance, is good.I am willing to check and record my blood pressure daily.My blood pressure is under 140/90 mmHg, and if needed, I'm managing it with up to three medications.I am not pregnant or breastfeeding, and I have a negative pregnancy test.I have vitiligo or hormone deficiencies like type I diabetes or thyroid issues, but they are under control with medication.My heart's pumping ability is below normal, and I've had specific heart-related treatments or conditions.I have or had an autoimmune disease that could worsen or needs steroids.I do not have an active infection, including tuberculosis.I am postmenopausal or cannot become pregnant, confirmed by a recent test.I have had signs of a blocked intestine recently or in the last 3 months.I am on antiviral treatment for active hepatitis B or C.My hemoglobin level is at least 10 mg/dL without recent blood transfusions.Your platelet count should be at least 100 billion per liter within the 28 days before taking the study drug.I have not had a bone marrow or cord blood transplant.I am not taking certain strong medications or those affecting heart rhythm recently.I had a gastrointestinal perforation but it's been stable for over 6 months.I do not have any severe illnesses that could interfere with the study.I have been diagnosed with MDS, t-AML, or have symptoms suggesting these conditions.I can swallow pills and don't have stomach issues affecting medicine absorption.Your liver function test results should not be more than three times the upper limit of normal within the last 28 days before starting the study drug.I have a controlled autoimmune condition without needing strong medication.I can care for myself and have been stable for the last two weeks.I don't need steroids for brain metastases and have stable disease after spinal cord compression treatment.I can have one more strong chemotherapy for my recurring or persistent cancer before joining this study.I do not have HIV due to potential drug interactions and increased infection risk.I have had more than one treatment with immune therapy.I have not been in a trial for cediranib or olaparib, but may have had bevacizumab.
Research Study Groups:
This trial has the following groups:- Group 1: Arm VI (cediranib maleate, durvalumab)
- Group 2: Arm V (olaparib, durvalumab)
- Group 3: Arm I (cediranib maleate)
- Group 4: Arm II (olaparib)
- Group 5: Arm III (cediranib maleate, olaparib)
- Group 6: Arm IV (olaparib, capivasertib)
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.
Endometrial Carcinoma Patient Testimony for trial: Trial Name: NCT03660826 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the risks associated with taking Cediranib Maleate?
"While there is some data to support the safety of Cediranib Maleate, it only received a 2 because this drug is still in Phase 2 trials and has yet to demonstrate efficacy in human clinical trials."
Answered by AI
Are there any other case studies of Cediranib Maleate's effects?
"Cediranib Maleate was first researched in 2005 and, as of now, 223 trials have been completed. 515 more are currently ongoing with a large number based in Longmont, Colorado."
Answered by AI
Have there been similar studies to this one in the past?
"There are presently 515 active studies for Cediranib Maleate across 1970 cities and 65 countries. The initial trial for Cediranib Maleate was conducted in 2005. The trial, sponsored by AstraZeneca, involved 98 participants and completed its Phase 1 drug approval stage. Since 2005 years, 223 trials have been completed."
Answered by AI
What are the primary indications for Cediranib Maleate?
"Cediranib Maleate is often used to treat disease. However, it has also been known to be effective in treating other conditions such as primary peritoneal cancer and advance directives."
Answered by AI
How many patients will be participating in this clinical trial at most?
"168 individuals that meet the pre-determined qualifications are necessary for this research to move forward. Those who are interested can inquire about participating at sites like Longmont United Hospital or Cancer Center of Western Wisconsin."
Answered by AI
Are individuals currently being recruited for this research project?
"Yes, this clinical trial is recruiting patients as of the most recent update on November 9th, 2022. The initial posting occurred on September 4th, 2018."
Answered by AI
Is this trial taking place in numerous states across the country?
"This trial currently has 100 enrollees, with patients coming from Longmont United Hospital in Longmont, Cancer Center of Western Wisconsin in New Richmond, University of Missouri - Ellis Fischel in Columbia, and other locations."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Lafayette Family Cancer Center-EMMC
Saint Rita's Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
Because i would be to be in study what they can find as researchers so i dont know if i join and should i get paid for the test? I never tried this before but i would like try …i would know about this information im so interested.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long it will take?
PatientReceived 2+ prior treatments
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