Gedatolisib Combination for Breast Cancer

Recruiting at 187 trial locations

Overseen By Nadene Zack, MS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Celcuity Inc

Must be taking: LHRH agonists

Must not be taking: PI3K inhibitors, Akt inhibitors

Disqualifiers: Type 1 diabetes, Brain metastases, Cardiovascular abnormalities, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 months

674 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

Are You a Good Fit for This Trial?

This trial is for adults with HR+/HER2- advanced breast cancer that's spread or can't be removed by surgery. It includes both men and women, but pre-menopausal women must use LHRH agonists. Participants need measurable disease, an ECOG status of 0-2, and no recent progression on similar treatments.

Inclusion Criteria

My cancer got worse during or within a year after hormone therapy.

I can provide a sample for PIK3CA mutation testing.

I have received chemotherapy before or after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

Determine the gedatolisib dose with ribociclib

4 weeks

Treatment

Participants receive gedatolisib with fulvestrant and ribociclib or palbociclib, or standard-of-care control

48 months

Weekly visits for gedatolisib administration, monthly visits for palbociclib or ribociclib

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Gedatolisib
• Palbociclib or Ribociclib

Trial Overview The study compares Gedatolisib combined with Fulvestrant and CDK4/6 Inhibitors (Palbociclib or Ribociclib) against just Palbociclib/Ribociclib with Fulvestrant in patients. The goal is to see if adding Gedatolisib improves treatment outcomes.

How Is the Trial Designed?

Group I: Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant Experimental Treatment 2 Interventions

Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off

Group II: Arm B: Palbociclib or Ribociclib + Fulvestrant Active Control 2 Interventions

Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle

Who Is Running the Clinical Trial?

Celcuity Inc

Lead Sponsor

Trials

9

Recruited

1,600+