Copanlisib + Fulvestrant for Hormone Receptor-Positive Cancers

Recruiting in Palo Alto (17 mi)

Overseen byTimothy Yap

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of copanlisib in combination with fulvestrant in advanced hormone receptor-positive (HR+) solid tumors harboring alterations that activate the Phosphatidylinositol-3 kinase (PI3K) pathway.

Research Team

Timothy Yap

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with advanced hormone receptor-positive solid tumors, including ovarian, endometrial, or breast cancer. Participants must have specific genetic alterations in the PI3K pathway and no available standard therapy that prolongs survival. They should be healthy enough to follow the study protocol and not pregnant or breastfeeding. Men must use barrier contraception.

Inclusion Criteria

My cancer is ER+ or PR+ and has spread beyond its original site.

I am able to get out of my bed or chair and move around.

There are no standard treatments left that can extend my life.

See 7 more

Exclusion Criteria

I have another cancer that is getting worse or needs treatment.

It's been over 4 weeks or 5 half-lives since my last chemotherapy or experimental treatment.

I am currently being treated for active hepatitis B or C.

See 14 more

Treatment Details

Interventions

Copanlisib (PI3K Inhibitor)
Fulvestrant (Hormone Therapy)

Trial OverviewThe trial tests the effectiveness and safety of combining copanlisib (a PI3K inhibitor) with fulvestrant in treating cancers that are positive for estrogen/progesterone receptors and have certain genetic changes activating the PI3K pathway.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose expansion:Experimental Treatment2 Interventions

The dose expansion part will enroll in 3 indication-specific cohorts with 13 to 26 patients

Group II: Part 1: Dose confirmationExperimental Treatment2 Interventions

Up to 6 evaluable patients to confirm a single combination dose of copanlisib and fulvestrant