Description:
Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment
of triple negative breast cancer
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
| Drug | Synonyms | Arms |
|---|
| Gedatolisib | | Gedatolisb + PTK7-ADC |
| PTK7-ADC | PF-06647020 | Gedatolisb + 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
| Name | Type | Description | Interventions |
|---|
| Gedatolisb + PTK7-ADC | Experimental | | |
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: | Completed |
| Lead Sponsor: | Kathy Miller |
Trial Keywords
Last Updated
January 7, 2021
