Ribociclib + Letrozole for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of two drugs, Ribociclib and Letrozole, in treating low-grade serous cancer of the ovary, fallopian tube, or peritoneum. The goal is to determine if these medications can manage this slow-growing cancer. Suitable participants have experienced a recurrence of this cancer and have not previously taken certain similar medications. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial requires you to stop taking certain medications, especially those that strongly affect liver enzymes (CYP3A4) or prolong the QT interval, at least 7 days before starting the study drug. If you're on tamoxifen or toremifene, a washout period (time without taking the medication) of 5 half-lives is needed before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using Ribociclib and Letrozole together yields promising results for treating certain cancers. In earlier studies, this combination slowed the progression of cancer in many patients for some time.
Regarding safety, studies indicate that patients generally tolerate this treatment well. Some may experience fatigue or nausea, but these side effects are usually manageable. Ribociclib and Letrozole are already used together for other conditions, suggesting they are generally safe.
Overall, research supports this combination as a safe option for patients, with many finding the side effects acceptable. However, individual experiences may vary with any treatment.12345Why are researchers excited about this trial's treatments?
Ribociclib and letrozole are unique because they combine a targeted approach with hormone therapy to treat ovarian cancer. Unlike standard treatments, which often rely on chemotherapy, this duo specifically targets cancer cell growth. Ribociclib works by inhibiting cyclin-dependent kinases 4 and 6 (CDK4/6), crucial for cancer cell division, while letrozole reduces estrogen production, a hormone that can fuel certain cancers. Researchers are excited about this combination because it offers a more tailored treatment option that could potentially improve outcomes for patients with ovarian cancer by slowing tumor progression and reducing side effects associated with more aggressive therapies.
What evidence suggests that Ribociclib and Letrozole might be an effective treatment for ovarian cancer?
Research has shown that using ribociclib and letrozole together holds promise for treating low-grade serous ovarian cancer. Studies have found that this combination can slow the cancer's growth in many women with this type of cancer. Specifically, women whose estrogen receptor-positive ovarian cancer has returned have experienced positive outcomes. This suggests the treatment might effectively manage the disease. The evidence supports the potential of ribociclib and letrozole to help control this specific type of ovarian cancer.15678
Who Is on the Research Team?
Brian Slomovitz, MD
Principal Investigator
GOG
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ribociclib 600mg oral daily for 3 weeks then 1 week off plus Letrozole 2.5 mg oral daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Letrozole
- Ribociclib
Letrozole is already approved in United States, European Union, Canada for the following indications:
- Breast cancer in postmenopausal women
- Increasing the chance of ovulation in women with polycystic ovary syndrome
- Early breast cancer in postmenopausal women
- Advanced breast cancer in postmenopausal women
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- First-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gynecologic Oncology Group
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania