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.
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.
I am 18 years old or older.
My tumor has PI3K or PTEN gene changes.
Exclusion Criteria
I have another cancer that is getting worse or needs treatment.
I am currently being treated for active hepatitis B or C.
I have been diagnosed with HIV.
I have Type 1 diabetes.
I am currently taking warfarin or similar blood thinners.
I have HER2 positive breast cancer.
I have previously been treated with fulvestrant or a PI3K inhibitor.
My cancer has spread to my brain or spinal cord.
My type 2 diabetes is not under control.
I have serious heart problems that are not under control.
I have or had lung inflammation causing symptoms.
I am not taking strong drugs that affect liver enzyme CYP3A4.
Treatment Details
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.
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
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
BayerIndustry Sponsor