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

NCT03243331

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
  • Official Title: An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0613
  • NCT ID: NCT03243331

Conditions

  • Triple Negative Breast Cancer
  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
GedatolisibGedatolisb + PTK7-ADC
PTK7-ADCPF-06647020Gedatolisb + PTK7-ADC

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Gedatolisb + PTK7-ADCExperimental
  • Gedatolisib
  • PTK7-ADC

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure:Efficacy in all enrolled subjects
Time Frame:18 weeks
Safety Issue:
Description:efficacy as determined by clinical benefit at 18 weeks
Measure:Overall response rate in all enrolled subjects
Time Frame:through study completion i.e. up to 1 year
Safety Issue:
Description:efficacy as determined by overall response rate
Measure:Progression free survival in all enrolled subjects
Time Frame:through study completion i.e. up to 1 year
Safety Issue:
Description:efficacy as determined by progression free survival
Measure:Pharmacodynamic determination of inhibition of PI3k signaling
Time Frame:Cycle 1 Day 15
Safety Issue:
Description: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.
Measure:Pharmacodynamic determination modulation of Wnt pathway
Time Frame:Cycle 1 Day 15
Safety Issue:
Description: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.
Measure:Pharmacodynamic determination modulation of Wnt pathway
Time Frame:Cycle 1 Day 15
Safety Issue:
Description:RNA sequencing of tissue collected at screening and Cycle 1 Day 1 to compare Wnt pathway expression after treatment

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Kathy Miller

Trial Keywords

  • Breast Cancer

Last Updated

August 7, 2017