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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

Timeline

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

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I have stored samples of my tumor.

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My breast cancer is confirmed and advanced.

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I do not have cancer that has spread to my brain or spinal cord.

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I am not pregnant or breastfeeding.

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I am willing to use two effective birth control methods.

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I am a man who can father children and will use birth control.

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I have advanced triple negative breast cancer without known BRCA gene mutations.

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I do not have a history of type I diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gedatolisib

2018

Completed Phase 1

~160

Talazoparib

2021

Completed Phase 2

~2770

0 / 8Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

Kari Wisinski 2019. "Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03911973.