An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer

January 5, 2021 updated by: Kathy Miller
Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Iu Simon Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Metastatic Triple-negative Breast Cancer
  • Willingness to undergo tumor biopsy
  • Patients must have received at least 1 prior chemotherapy regimen for metastatic disease

Exclusion Criteria:

  • Previous treatment with mTOR inhibitor
  • Untreated brain metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gedatolisb + PTK7-ADC
Drug: Gedatolisib
Gedatolisb will be intravenously administered on Day 1, Day 8 and Day 15 of every 21 day cycle at a dose of 110 mg or 180mg depending on cohort assignment.
Drug: PTK7-ADC
PTK7-ADC will be administered on Day 1 of every 21 day cycle at a dose of 1.4mg/kg or 2.8 mg/kg depending on cohort assignment.
Other Names:
  • PF-06647020

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0
Time Frame: through study completion i.e. up to 1 year
safety and toxicity data will be assessed using NCI CTCAE v4.0 and tabulated and reported
through study completion i.e. up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy in all enrolled subjects
Time Frame: 18 weeks
efficacy as determined by clinical benefit at 18 weeks
18 weeks
Overall response rate in all enrolled subjects
Time Frame: through study completion i.e. up to 1 year
efficacy as determined by overall response rate
through study completion i.e. up to 1 year
Progression free survival in all enrolled subjects
Time Frame: through study completion i.e. up to 1 year
efficacy as determined by progression free survival
through study completion i.e. up to 1 year
Pharmacodynamic determination of inhibition of PI3k signaling
Time Frame: Cycle 1 Day 15
Pathological H-score will be determined from tissue obtained at screening and Cycle 1 Day 15. H-score will be compared to calculate percentage inhibition between samples.
Cycle 1 Day 15
Pharmacodynamic determination modulation of Wnt pathway
Time Frame: Cycle 1 Day 15
pathological H-score will be determined from tissue obtained at screening and Cycle 1 Day 15. H-score will be compared to calculate percentage change in expression between samples.
Cycle 1 Day 15
Pharmacodynamic determination modulation of Wnt pathway
Time Frame: Cycle 1 Day 15
RNA sequencing of tissue collected at screening and Cycle 1 Day 1 to compare Wnt pathway expression after treatment
Cycle 1 Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kathy Miller

Investigators

  • Principal Investigator: Milan Radovich, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2018

Primary Completion (Actual)

May 27, 2020

Study Completion (Actual)

May 27, 2020

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 9, 2017

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUSCC-0613

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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