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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03243331
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Kathy Miller, Indiana University

Study Description
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Brief Summary:
Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Metastatic Breast Cancer Drug: Gedatolisib Drug: PTK7-ADC Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Study will enroll 3 patients to the cohort 1 dose level. If 0 of 3 patients experience a DLT, the study will proceed to cohort 2. If 1 patient experiences a DLT, 3 additional patients will be enrolled into cohort 1. If 1 of 6 patients experience a DLT, the study will proceed and 3 patients will be enrolled to the cohort 2 dose level. If 0 patients experience a DLT in cohort 2, the study will proceed to cohort 3. If 1 patient experiences a DLT at cohort 2, 3 additional patients will be enrolled into cohort 2. If the study proceeds to cohort 3, 3 patients will be enrolled at this dose level. If 0 patients experience a DLT, the study will enroll an additional 3 patients at the cohort 3 dose level to better define the safety profile. If 1 of 3 patients experiences a DLT at cohort 3, 3 additional patients will still be enrolled into cohort 3. If 1 of 6 patients experience a DLT, the study will complete.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
Actual Study Start Date : January 19, 2018
Actual Primary Completion Date : May 27, 2020
Actual Study Completion Date : May 27, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: PF-06647020


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Efficacy in all enrolled subjects [ Time Frame: 18 weeks ]
    efficacy as determined by clinical benefit at 18 weeks

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243331


Locations
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United States, Indiana
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Kathy Miller
Investigators
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Principal Investigator: Kathy Miller, MD Indiana University
Principal Investigator: Milan Radovich, PhD Indiana University
More Information
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Responsible Party: Kathy Miller, Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03243331    
Other Study ID Numbers: IUSCC-0613
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathy Miller, Indiana University:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Gedatolisib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action