Ribociclib + Letrozole for Ovarian Cancer

Recruiting at 26 trial locations

Overseen By Jennifer Klein, MEd

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Gynecologic Oncology Group

Must be taking: Hormonal suppression

Must not be taking: CYP3A4 inducers, QT prolongers

Disqualifiers: Concurrent malignancy, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Indefinite, assessed up to 5 years

51 Participants Needed

Trial Summary

What is the purpose of this trial?

The study evaluates the response to treatment with Ribociclib and Letrozole in patients with low grade serous cancer of the ovary, fallopian tube or peritoneum.

Research Team

Brian Slomovitz, MD

Principal Investigator

GOG

Eligibility Criteria

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

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.

Exclusion Criteria

You are allergic to any of the ingredients in the drugs ribociclib or letrozole.

My CNS condition meets all specific criteria.

I have a family history of sudden death or long QT syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ribociclib 600mg oral daily for 3 weeks then 1 week off plus Letrozole 2.5 mg oral daily

Indefinite, assessed up to 5 years

Visits every 4 weeks for toxicity assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• Letrozole
• Ribociclib

Trial Overview 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.

Participant Groups

Group I: Ribociclib and letrozole Experimental Treatment 2 Interventions

Ribociclib 600mg oral daily for 3 weeks then 1 week off plus Letrozole 2.5 mg oral daily

Letrozole is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Femara for:

• Breast cancer in postmenopausal women
• Increasing the chance of ovulation in women with polycystic ovary syndrome

Approved in European Union as Letrozole for:

• Early breast cancer in postmenopausal women
• Advanced breast cancer in postmenopausal women

Approved in Canada as Letrozole for:

• 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

Who Is Running the Clinical Trial?

Gynecologic Oncology Group

Lead Sponsor

Trials

251

Recruited

65,400+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

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