Study on Combining Olaparib, Durvalumab, Cediranib, and Capivasertib for Recurrent or Resistant Endometrial Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT03660826

This clinical trial is exploring different combinations of medications to treat endometrial cancer that has returned or is not responding to treatment. The study aims to find out if these combinations can better control the cancer compared to standard treatments.

Patient Parameters

Parameter	Options

Program Overview

This study is testing various combinations of drugs, including olaparib, durvalumab, cediranib, and capivasertib, to see if they can help control endometrial cancer that has come back or is not responding to other treatments. These drugs work by blocking certain enzymes needed for cancer cell growth or by helping the immune system attack cancer cells. The goal is to see if these combinations can prevent the cancer from growing or spreading better than usual care.

Description

The study is divided into several parts, each testing different combinations of drugs:

Arm I: Patients take cediranib daily. The treatment cycle repeats every 28 days unless the cancer progresses or side effects become unacceptable.
Arm II: Patients take olaparib twice daily. The treatment cycle repeats every 28 days unless the cancer progresses or side effects become unacceptable.
Arm III: Patients take both olaparib and cediranib. The treatment cycle repeats every 28 days unless the cancer progresses or side effects become unacceptable.
Arm IV: Patients take olaparib daily and capivasertib for four days each week. The treatment cycle repeats every 28 days unless the cancer progresses or side effects become unacceptable.
Arm V: Patients take olaparib daily and receive durvalumab through an IV once every cycle. The treatment cycle repeats every 28 days unless the cancer progresses or side effects become unacceptable.
Arm VI: Patients take cediranib daily for five days each week and receive durvalumab through an IV once every cycle. The treatment cycle repeats every 28 days unless the cancer progresses or side effects become unacceptable.

Throughout the study, patients will have regular blood tests, scans, and other evaluations to monitor their health and the cancer's response to treatment. After completing the study treatment, patients will have follow-up visits every three months for two years, then every six months for three more years.

Eligibility Criteria

Inclusion Criteria

Have endometrial cancer that has returned or is not responding to treatment.
Have measurable or detectable disease as defined by specific medical criteria.
Have had at least one prior chemotherapy regimen for endometrial cancer.
May have received non-cytotoxic therapy, including immunotherapy, but not the specific drugs being tested in this study.
Be female, aged 18 or older, and weigh more than 30 kg.
Agree to use effective contraception if of childbearing potential.
Have a good performance status, meaning able to carry out daily activities with minimal restrictions.
Have adequate blood counts and organ function as determined by specific tests.
Be able to swallow and retain oral medications.
Have controlled blood pressure and thyroid function.
Have a life expectancy of more than 16 weeks.
Agree to follow study procedures and provide informed consent.

Exclusion Criteria

Have previously participated in a trial involving the drugs being tested.
Have had recent chemotherapy, radiotherapy, or investigational treatments.
Have more than one prior line of immune checkpoint therapy.
Have current or recent bowel obstruction.
Have uncontrolled illnesses, including certain heart or lung conditions.
Be pregnant or breastfeeding.
Have active infections like HIV or hepatitis.
Have a history of stroke or heart attack within the last six months.
Have other serious medical conditions that could interfere with the study.
Have a history of allergic reactions to similar drugs.
Have active autoimmune diseases requiring treatment.

Locations

FACILITY	ZIP	CITY	STATE
University of Alabama at Birmingham Cancer Center	35233	Birmingham	Alabama
Anchorage Associates in Radiation Medicine	98508	Anchorage	Alaska
Anchorage Radiation Therapy Center	99504	Anchorage	Alaska
Alaska Breast Care and Surgery LLC	99508	Anchorage	Alaska
Alaska Oncology and Hematology LLC	99508	Anchorage	Alaska
Alaska Women's Cancer Care	99508	Anchorage	Alaska
Anchorage Oncology Centre	99508	Anchorage	Alaska
Katmai Oncology Group	99508	Anchorage	Alaska
Providence Alaska Medical Center	99508	Anchorage	Alaska
Fairbanks Memorial Hospital	99701	Fairbanks	Alaska

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