Copanlisib + Fulvestrant for Hormone Receptor-Positive Cancers

Overseen by Timothy 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.

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.

Treatment Details

Interventions

• Copanlisib (PI3K Inhibitor)
• Fulvestrant (Hormone Therapy)

Trial Overview The 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

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

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

Group II: Part 1: Dose confirmation Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

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Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD