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PI3K/mTOR Inhibitor

Gedatolisib for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Kari Wisinski, MD
Research Sponsored by Kari Wisinski
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Archived tumor tissue available
Subjects with histologically confirmed breast cancer that is advanced
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat advanced breast cancer that is negative for HER2 and either triple negative or BRCA1/2 positive.

Who is the study for?
This trial is for adults with advanced HER2 negative breast cancer that's either triple negative or BRCA1/2 positive. Participants must have measurable disease, be able to take oral meds, and not be pregnant or breastfeeding. They should agree to use contraception if necessary and have no major health issues like diabetes, active infections, or a history of certain heart conditions.Check my eligibility
What is being tested?
The study tests the combination of gedatolisib plus talazoparib in treating advanced breast cancer. It aims to find the right dose and assess how effective this combo is against specific types of breast cancer that lack three common receptors (triple-negative) or carry BRCA mutations.See study design
What are the potential side effects?
Potential side effects may include reactions related to gastrointestinal function due to talazoparib absorption issues, liver problems from hepatitis B/C risks, blood disorders such as myelodysplastic syndrome or leukemia, increased risk of infection requiring systemic therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I have stored samples of my tumor.
My breast cancer is confirmed and advanced.
I do not have cancer that has spread to my brain or spinal cord.
I am not pregnant or breastfeeding.
I am willing to use two effective birth control methods.
I am a man who can father children and will use birth control.
I have advanced triple negative breast cancer without known BRCA gene mutations.
I do not have a history of type I diabetes.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of talazoparib in combination with gedatolisib (Phase I)
Objective Response Rate (ORR) (Phase II)
Secondary outcome measures
Clinical Benefit Rate (CBR) at 16 weeks
Duration of Response (DOR)
Overall Survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Talazoparib + GedatolisibExperimental Treatment2 Interventions
Talazoparib + Gedatolisib Phase 1: Dose Level -1: Gedatolisib 150mg IV, Days 1,8,15,22; Talazoparib 0.75 mg/orally qd, Days 1-28 Dose Level 1: Gedatolisib 180mg IV, Days 1,8,15,22; Talazoparib 0.75 mg/orally qd, Days 1-28 Dose Level 2: Gedatolisib 180mg IV, Days 1,8,15,22; Talazoparib 1.00 mg/orally qd, Days 1-28 Phase 2: Gedatolisib 180 mg IV on days 1, 8, 15 and 22; Talazoparib 1.00 mg once daily, Days 1-28. Subjects receiving weekly gedatolisib may continue current regimen or may switch to gedatolisib 180 mg IV on days 1, 8, and 15; Talazoparib 1.00 mg once daily, Days 1-28 (3 weeks on/ 1 week off). All changes will be permanent.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1
Completed Phase 2

Find a Location

Who is running the clinical trial?

Celcuity IncIndustry Sponsor
7 Previous Clinical Trials
979 Total Patients Enrolled
3 Trials studying Breast Cancer
898 Patients Enrolled for Breast Cancer
Kari WisinskiLead Sponsor
2 Previous Clinical Trials
81 Total Patients Enrolled
Celcuity, Inc.Industry Sponsor
6 Previous Clinical Trials
925 Total Patients Enrolled
3 Trials studying Breast Cancer
898 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Are patients currently being recruited for this trial?

"Yes, this research is currently looking for volunteers to enroll. The trial was announced on April 17th, 2019 and has since been updated January 18th of this year."

Answered by AI

Are there any other Gedatolisib studies that have been completed?

"There are currently 61 clinical trials underway for Gedatolisib. 3 of those trials are in the final stage, Phase 3. Most of the research is being conducted in Kashiwa, Chiba; however, there are 2322 total locations running Gedatolisib trials."

Answered by AI

What are the primary objectives of this research?

"According to the study's sponsor, Pfizer, the primary objective of this 24-month long trial is to establish the Maximum Tolerated Dose (MTD) of talazoparib when used in combination with gedatolisib. Additionally, this clinical study will measure secondary outcomes including the Objective Response Rate (defined as confirmed complete response + confirmed partial response according to RECIST 1.1 criteria), Clinical Benefit Rate (CBR; defined as sum of confirmed complete plus partial and measurable disease responses plus stable disease at 16 weeks), and Overall Survival rate."

Answered by AI

Are there different versions of this experiment being conducted in various locations?

"5 sites are currently running this study, with locations in Chicago, Iowa City and Madison. To reduce travel for participants, it is encouraged to enroll at the clinical trial site nearest you."

Answered by AI

How many subjects are involved in this research project?

"In order to run this trial, 54 patients who meet specific inclusion criteria must be recruited. The clinical trial is being administered by Pfizer at various locations, such as Northwestern University Feinberg School of Medicine in Chicago, Illinois and University of Iowa Hospital and Clinics in Iowa City, Iowa."

Answered by AI
~6 spots leftby Apr 2025