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Aromatase Inhibitor
Ribociclib + Letrozole for Ovarian Cancer
Phase 2
Waitlist Available
Research Sponsored by Gynecologic Oncology Group
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 (PS) 0-2
Patients who were treated with letrozole or another aromatase inhibitor for other indications must have not taken the drug for 6 months prior to initiating letrozole for this trial and may not have progressed on treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks assessed up to 5 years
Awards & highlights
Study Summary
This trial looks at whether a combination of two drugs is effective in treating a certain type of ovarian cancer.
Who is the study for?
This trial is for adults over 18 with low-grade serous ovarian, fallopian tube, or peritoneal cancer that has returned. They must have measurable disease and cannot have used CDK inhibitors before or aromatase inhibitors like letrozole in the last 6 months. Participants need to be healthy enough overall (ECOG PS 0-2) and able to take oral medication.Check my eligibility
What is being tested?
The study tests Ribociclib combined with Letrozole's effectiveness on patients with recurrent low-grade serous carcinoma. It aims to see how well these drugs work together in treating this type of cancer.See study design
What are the potential side effects?
Ribociclib may cause fatigue, nausea, hair loss, constipation, diarrhea, and blood count changes. Letrozole can lead to hot flashes, joint pain, weakness, sweating at night and osteoporosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
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I haven't taken letrozole or similar drugs for 6 months and didn't worsen on them.
Select...
My ovaries are no longer functioning.
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I have never taken drugs for cancer that target cell growth and I haven't used letrozole or similar drugs in the last 6 months.
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I have never taken medication that blocks cell growth.
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I can swallow pills.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 4 weeks assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks assessed 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
Response rate
Secondary outcome measures
Clinical benefit (CR, PR, SD) rate
Overall survival
Progression-free survival
+1 moreOther outcome measures
ER expression
Mutation analysis of genomic signatures
PR expression
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ribociclib and letrozoleExperimental Treatment2 Interventions
Ribociclib 600mg oral daily for 3 weeks then 1 week off plus Letrozole 2.5 mg oral daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~2330
Letrozole
2002
Completed Phase 4
~3240
Find a Location
Who is running the clinical trial?
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,875 Total Patients Enrolled
NovartisIndustry Sponsor
1,610 Previous Clinical Trials
2,719,219 Total Patients Enrolled
Brian Slomovitz, MDStudy ChairGOG
3 Previous Clinical Trials
260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself and perform daily activities.I have had any number of previous treatments.I am willing and able to follow the study's requirements.You are allergic to any of the ingredients in the drugs ribociclib or letrozole.My CNS condition meets all specific criteria.You have read and agreed to the study's information and can follow the study's rules.I have a family history of sudden death or long QT syndrome.I haven't taken letrozole or similar drugs for 6 months and didn't worsen on them.I have a digestive system condition that affects how medicines work in my body.You cannot have participated in any other medical research or taken any experimental drugs within the last 30 days before starting this study.I am currently taking warfarin or a similar blood thinner.I have taken steroids within the last 2 weeks or am still experiencing their side effects.I am not taking any strong medications that affect liver enzymes or heart rhythm.I have had a bone marrow or stem cell transplant.I do not have functioning ovaries, or I am in menopause confirmed by tests.My cancer is a low-grade serous carcinoma, confirmed by a specialist.My ovaries are no longer functioning.I haven't had cancer, except for certain skin or cervical cancers, in the last 3 years and don't have brain metastases.My cancer has come back and can be measured.My cancer is a confirmed low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum.My low-grade serous carcinoma diagnosis has been confirmed by a specialist.All side effects from my previous cancer treatments are mild or gone.My blood tests show my organs and bone marrow are working well.I had recent radiation therapy and still experience side effects.I have not had major surgery in the last 2 weeks or still have major side effects from it.I have never taken drugs for cancer that target cell growth and I haven't used letrozole or similar drugs in the last 6 months.My liver disease is moderately to severely advanced.I stopped taking tamoxifen or toremifene 5 half-lives ago before joining the study.I do not have serious, uncontrolled heart problems.I cannot stop my current medications for 7 days before starting the study drug.I have a known history of HIV.I am using effective birth control if I can become pregnant.I have never taken medication that blocks cell growth.I may have had any number of previous treatments.My cancer is a mix of low and high-grade serous carcinoma.I can swallow pills.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Ribociclib and letrozole
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.
Are there any open enrollment opportunities for this clinical research endeavor?
"As indicated on clinicaltrials.gov, this medical trial is presently recruiting patients with an initial posting date of December 14th 2018 and a most recent update as recently as February 15th 2022."
Answered by AI
Have other experiments utilized this therapeutic modality?
"Initially researched at the National Institutes of Health Clinical Center in 1995, this medicinal intervention has since become increasingly popular with 217 studies completed. As a result, 185 ongoing clinical trials are active - many taking place around Hackensack, New jersey."
Answered by AI
What potential dangers should individuals be aware of in using this treatment?
"The safety of this treatment was assessed to be a 2 on our team's scale due to the Phase 2 nature of the trial, which implies lack of efficacy data but some evidence in support of its safety."
Answered by AI
How many individuals are being considered for enrollment in this research project?
"A total of 51 participants, who satisfy the prerequisites for inclusion in this clinical trial, are required. Patients can partake from multiple sites such as Hackensack University Medical Center located in Hackensack, New jersey and Miami Valley Hospital based out of Centerville Ohio."
Answered by AI
For what ailments is this proposed remedy typically prescribed?
"This therapeutic intervention is often prescribed to treat cancerous tumours. It can also be effective at ameliorating conditions like advanced HR + HER2 - breast cancer, anovulatory cycle, and tamoxifen."
Answered by AI
Are there many North American sites undertaking this clinical trial?
"Patients are able to sign up for the trial at 27 different clinics, such as Hackensack University Medical Center in Hackensack, Miami Valley Hospital in Centerville, and NorthShore University HealthSystem in Evanston."
Answered by AI
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