Copanlisib + Fulvestrant for Hormone Receptor-Positive Cancers
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot use certain strong enzyme inducers or inhibitors from 14 days before starting the study. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug combination Copanlisib + Fulvestrant for hormone receptor-positive cancers?
Research shows that Fulvestrant is effective in treating advanced hormone receptor-positive breast cancer, especially in patients who are sensitive to endocrine therapy. It has been compared favorably to other treatments like anastrozole, suggesting its potential benefit in combination therapies.12345
Is the combination of Copanlisib and Fulvestrant safe for humans?
Copanlisib has been studied in various cancers and generally shows a manageable safety profile, with common side effects including high blood pressure, diarrhea, and high blood sugar. Fulvestrant, also known as Faslodex, is commonly used in hormone receptor-positive breast cancer and is generally well-tolerated, though it can cause side effects like nausea and injection site pain.678910
How is the drug combination of Copanlisib and Fulvestrant unique for hormone receptor-positive cancers?
The combination of Copanlisib and Fulvestrant is unique because it pairs Fulvestrant, a pure estrogen receptor antagonist that blocks and degrades estrogen receptors, with Copanlisib, a drug that inhibits specific enzymes involved in cancer cell growth. This combination targets both hormone-driven and growth factor-driven pathways, potentially offering a more comprehensive approach to treating hormone receptor-positive cancers compared to treatments that target only one pathway.511121314
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Confirmation
Evaluate the safety, tolerability, and dose-limiting toxicities of copanlisib in combination with fulvestrant to confirm the recommended phase 2 doses
Dose Expansion
Assess the efficacy of copanlisib in combination with fulvestrant in 3 indication-specific cohorts
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Copanlisib
- Fulvestrant
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Bayer
Industry Sponsor
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