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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03243331
Other study ID # IUSCC-0613
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 19, 2018
Est. completion date May 27, 2020

Study information

Verified date January 2021
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date May 27, 2020
Est. primary completion date May 27, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States IU Simon Cancer Center Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Kathy Miller

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0 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 Efficacy in all enrolled subjects efficacy as determined by clinical benefit at 18 weeks 18 weeks
Secondary Overall response rate in all enrolled subjects efficacy as determined by overall response rate through study completion i.e. up to 1 year
Secondary Progression free survival in all enrolled subjects efficacy as determined by progression free survival through study completion i.e. up to 1 year
Secondary Pharmacodynamic determination of inhibition of PI3k signaling 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
Secondary Pharmacodynamic determination modulation of Wnt pathway 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
Secondary Pharmacodynamic determination modulation of Wnt pathway RNA sequencing of tissue collected at screening and Cycle 1 Day 1 to compare Wnt pathway expression after treatment Cycle 1 Day 15
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