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PI3K Inhibitor

Copanlisib + Fulvestrant for Hormone Receptor-Positive Cancers

Phase 2
Waitlist Available
Led By Timothy Yap
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed ER+ and/or PR+ advanced or metastatic solid cancer including ovarian cancer (cohort 1), endometrial cancer (cohort 2), or breast cancer (cohort 3)
Eastern Cooperative Oncology Group (ECOG) performance status of .2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial looks at whether adding copanlisib to fulvestrant helps people with HR+ solid tumors that contain alterations that activate the PI3K pathway.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include high blood sugar levels, diarrhea, hypertension, neutropenia (low white blood cell count), liver enzyme elevation, fatigue, rash, nausea and hyperglycemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is ER+ or PR+ and has spread beyond its original site.
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I am able to get out of my bed or chair and move around.
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There are no standard treatments left that can extend my life.
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I am 18 years old or older.
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My tumor has PI3K or PTEN gene changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To establish the use of copanlisib in combination with fulvestrant administered to subjects with selected estrogen receptor-positive (ER+).

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fulvestrant
2012
Completed Phase 3
~2000
Copanlisib
2016
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,795 Total Patients Enrolled
46 Trials studying Ovarian Cancer
16,738 Patients Enrolled for Ovarian Cancer
BayerIndustry Sponsor
2,237 Previous Clinical Trials
25,326,971 Total Patients Enrolled
8 Trials studying Ovarian Cancer
389 Patients Enrolled for Ovarian Cancer
Timothy YapPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
884 Total Patients Enrolled
1 Trials studying Ovarian Cancer
804 Patients Enrolled for Ovarian Cancer

Media Library

Copanlisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05082025 — Phase 2
Ovarian Cancer Research Study Groups: Part 1: Dose confirmation, Part 2: Dose expansion:
Ovarian Cancer Clinical Trial 2023: Copanlisib Highlights & Side Effects. Trial Name: NCT05082025 — Phase 2
Copanlisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05082025 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what medical conditions is Copanlisib commonly prescribed?

"Copanlisib is commonly used to address this therapeutic procedure, but also has medical applications for individuals fighting pik3ca gene mutations, malignant neoplasms and disease progression."

Answered by AI

How many participants have been registered for this experiment?

"Affirmative. According to information listed on clinicaltrials.gov, this particular medical trial is actively seeking participants. This study was first posted on August 27th 2022 and the most recent amendment occurred September 27th of that same year. 78 patients need to be recruited from a single location."

Answered by AI

Has recruitment begun for the current trial participants?

"According to the clinicaltrials.gov website, this trial is actively recruiting potential participants. The study was initially published on August 27th 2022 and last modified on September 27th 2022."

Answered by AI

Have there been any other reports on the efficacy of Copanlisib?

"Currently, 163 clinical studies are devoted to researching copanlisib. Of those trials, 34 have entered phase 3 of the testing process. Although most locations for these studies can be found in Shanghai, there is a total of 7897 sites running tests concerning this particular medication."

Answered by AI

Has the government sanctioned Copanlisib for widespread utilization?

"Considering the Phase 2 designation, our team at Power assigned Copanlisib a rating of 2 in terms of safety as there is some evidence it may be safe but no data that supports its effectiveness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations
2022. "Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05082025.
~1 spots leftby Aug 2024
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