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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 below
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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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I have controlled colitis or chronic diarrhea, and haven't needed steroids for colitis.
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I have had Bevacizumab or one immune-checkpoint therapy, but not durvalumab, before joining this trial.
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My blood pressure is under 140/90 mmHg, and if needed, I'm managing it with up to three medications.
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I am using two reliable birth control methods during and 4 weeks after the study.
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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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I can have one more strong chemotherapy for my recurring or persistent cancer before joining this study.
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I have had one non-chemotherapy treatment for my cancer, but not with specific excluded drugs.
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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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I am a woman agreeing to use birth control and have a negative pregnancy test before the study.
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My kidney function, measured by creatinine clearance, is good.
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I am willing to check and record my blood pressure daily.
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I am postmenopausal or cannot become pregnant, confirmed by a recent test.
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My hemoglobin level is at least 10 mg/dL without recent blood transfusions.
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I can swallow pills and don't have stomach issues affecting medicine absorption.
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I can care for myself and have been stable for the last two weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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
~2790
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Biospecimen Collection
2004
Completed Phase 2
~1890
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
13,636 Previous Clinical Trials
40,929,495 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

Capivasertib (AKT Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03660826 — Phase 2
Endometrial Carcinoma Research Study Groups: Arm VI (cediranib maleate, durvalumab), Arm V (olaparib, durvalumab), Arm I (cediranib maleate), Arm II (olaparib), Arm III (cediranib maleate, olaparib), Arm IV (olaparib, capivasertib)
Endometrial Carcinoma Clinical Trial 2023: Capivasertib Highlights & Side Effects. Trial Name: NCT03660826 — Phase 2
Capivasertib (AKT Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03660826 — Phase 2
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
~44 spots leftby Apr 2025