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Hormone Therapy
Onapristone + Anastrozole for Endometrial Cancer
Phase 2
Waitlist Available
Led By Russell Schilder, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Females are only eligible for this study if they are postmenopausal. This is defined as meeting one of the following criteria: S/p total abdominal hysterectomy and bilateral salpingo-oopherectomy, Patients who are in menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 55 in the absence of other biological or physiological causes OR women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post-treatment
Awards & highlights
Study Summary
This trial tests a combination of drugs to treat endometrial cancer that hasn't responded to previous treatment. The drugs block hormones that can cause cancer cell growth.
Who is the study for?
This trial is for adults over 18 with hormone receptor positive endometrial cancer that hasn't improved after platinum/taxane chemotherapy. Participants must have tried no more than two treatments, be able to swallow pills, weigh over 30 kg, and have recovered from previous therapies. Women must be postmenopausal and not pregnant or nursing. People with certain heart conditions, untreated brain metastases, severe infections or recent major surgery are excluded.Check my eligibility
What is being tested?
The trial tests onapristone combined with anastrozole against refractory hormone receptor positive endometrial cancer. Onapristone blocks progesterone use by tumor cells while anastrozole inhibits estrogen production in the body. The goal is to see if this combination works better than anastrozole alone.See study design
What are the potential side effects?
Potential side effects may include hormonal imbalances leading to mood swings or hot flashes, gastrointestinal issues like nausea or diarrhea, fatigue due to low energy levels caused by the treatment's effect on hormones and possible liver function changes detectable through blood tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am a woman who has gone through menopause.
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My liver function tests are within the required range for my condition.
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My kidney function, measured by GFR, is adequate.
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I am 18 years old or older.
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I have had no more than 2 previous cancer treatments, including one with platinum/taxane.
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I have tried one platinum/taxane chemotherapy without success.
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My cancer is one of the specified types and not carcinosarcoma.
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I have a tumor or lymph node large enough to be measured by scans.
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I weigh more than 30 kilograms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Progression-Free Survival (PFS)
Secondary outcome measures
Disease Control Rate
Duration of Response
Quality of Life and pain score
+2 moreOther outcome measures
Estrogen receptor and progesterone receptor expression
Side effects data
From 2018 Phase 4 trial • 79 Patients • NCT0213753810%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (onapristone, anastrozole)Experimental Treatment6 Interventions
Patients receive onapristone PO BID and anastrozole PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles (24 months) until November 30, 2023 or in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anastrozole
2019
Completed Phase 4
~10090
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
444 Previous Clinical Trials
145,610 Total Patients Enrolled
Context Therapeutics Inc.Industry Sponsor
4 Previous Clinical Trials
112 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,139 Total Patients Enrolled
18 Trials studying Endometrial Carcinoma
8,838 Patients Enrolled for Endometrial Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have fully recovered from my previous radiation treatments.I am a woman who has gone through menopause.All my side effects from previous treatments are mild, except for possible moderate nerve pain and hair loss.I have had cancer treatment, including trial drugs, within the last 3 weeks.I haven't had chemotherapy, radiotherapy, immunotherapy, or major surgery in the last 3 weeks.You need to have a certain level of a type of white blood cell called neutrophils in your blood.Your platelet count is 100,000 per microliter or higher.Your bilirubin levels are within a certain range, unless you have Gilbert syndrome, in which case they can be slightly higher.My endometrial cancer tests show at least 1% ER or PR expression.My liver function tests are within the required range for my condition.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.I haven't taken any medication in the last 28 days that could affect my treatment.My kidney function, measured by GFR, is adequate.My brain metastasis has been stable or untreated for 6 months or more.Your hemoglobin level is 9 grams per deciliter or higher.You have high levels of protein in your urine.I am 18 years old or older.I have severe heart disease.I haven't had cancer, except for certain skin, bladder, or cervical cancers, in the last 3 years.I have a severe fluid buildup in my chest or around my heart.I am currently being treated for an infection.I have had no more than 2 previous cancer treatments, including one with platinum/taxane.I have tried one platinum/taxane chemotherapy without success.My cancer is one of the specified types and not carcinosarcoma.I have a tumor or lymph node large enough to be measured by scans.I have fully recovered from any major surgery before starting the study treatment.I have not taken hormonal cancer treatments like tamoxifen in the last 2 months.I am not pregnant or nursing.I weigh more than 30 kilograms.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (onapristone, anastrozole)
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.
Is there room for more patients in this research project?
"Yes, this study is still recruiting patients according to the latest update on clinicaltrials.gov. This particular trial was first advertised on 1/28/2021 with the most recent update being on 7/5/2022."
Answered by AI
How large is the test group for this experiment?
"The clinical trial is still recruiting patients, according to the most recent information from clinicaltrials.gov. The trial was posted on 1/28/2021 and edited on 7/5/2022. They are looking for 25 patients total at 3 sites."
Answered by AI
Are there long-term repercussions to taking Anastrozole?
"This drug has undergone Phase 2 clinical trials, meaning that there is some data supporting its safety but none yet demonstrating its efficacy. Our team at Power rates its safety as a 2 on a scale of 1 to 3."
Answered by AI
How does this research compare to other work that has been done on Anastrozole?
"Out of the total 76 clinical trials currently underway for Anastrozole, 26 are in Phase 3. Most of these studies are located in Pisa, Italy; however, there are 7961 research sites around the world testing this medication."
Answered by AI
What is the primary reason that doctors prescribe Anastrozole?
"Anastrozole can be used to combat breast cancer, malignant neoplasms, and hormone receptor unknown."
Answered by AI
Why was this trial started in the first place?
"The primary outcome of this trial is Progression-Free Survival (PFS), which will be assessed over a period of up to 1 year after treatment. Secondary outcomes include Disease Control Rate, Time to Response, and Type, frequency and severity of adverse events and laboratory abnormalities."
Answered by AI
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