Triple Negative Breast CancerPhase 1NCT03243331
An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
A Phase 1 study testing Gedatolisib and PTK7-ADC in people with Triple Negative Breast Cancer and Metastatic Breast Cancer, run by Kathy Miller at 1 site in United States.
Trial summary
Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Gedatolisib and PTK7-ADC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2018to 27 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic Triple-negative Breast Cancer
- Willingness to undergo tumor biopsy
- Patients must have received at least 1 prior chemotherapy regimen for metastatic disease
Who cannot join
- Previous treatment with mTOR inhibitor
- Untreated brain metastases
Trial locations and contacts
1 site in 1 country.
About this study
Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer
- Being tested
- Gedatolisib, PTK7-ADC
- Keywords
- Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GedatolisibDrug
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-ADCDrug
Also called PF-06647020
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.
| Study group | Role | What they receive |
|---|---|---|
| Gedatolisb + PTK7-ADC | Experimental | Not described Receives: Drug: Gedatolisib; Drug: PTK7-ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion i.e. up to 1 year
Secondary outcomes (6)
Efficacy in all enrolled subjects
efficacy as determined by clinical benefit at 18 weeks
Measured: 18 weeks
Overall response rate in all enrolled subjects
efficacy as determined by overall response rate
Measured: through study completion i.e. up to 1 year
Progression free survival in all enrolled subjects
efficacy as determined by progression free survival
Measured: through study completion i.e. up to 1 year
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.
Measured: Cycle 1 Day 15
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.
Measured: Cycle 1 Day 15
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
Measured: Cycle 1 Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start19 Jan 2018
- Primary completion27 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathy Miller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathy Miller, Indiana University
- Investigators
- Kathy Miller, MD, Principal investigator, Indiana UniversityMilan Radovich, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243331
- Sponsor's protocol ID
- IUSCC-0613
- Status last verified
- Jan 2021
- First submitted
- 3 Aug 2017
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03243331
- Acronym / sponsor ID
- IUSCC-0613
- Keywords
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kathy MillerUniversity, hospital or other
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gedatolisb + PTK7-ADC | Experimental | Drug: Gedatolisib, Drug: PTK7-ADC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Metastatic Triple-negative Breast Cancer
- Willingness to undergo tumor biopsy
- Patients must have received at least 1 prior chemotherapy regimen for metastatic disease
Key exclusion criteria (2 listed)
- Previous treatment with mTOR inhibitor
- Untreated brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GedatolisibGedatolisb 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 | Gedatolisb + PTK7-ADC |
| PTK7-ADCAlso: PF-06647020PTK7-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. | Drug | Gedatolisb + PTK7-ADC |
Primary outcome
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
6 secondary outcomes
Efficacy in all enrolled subjects
Time frame: 18 weeks
Overall response rate in all enrolled subjects
Time frame: 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
Pharmacodynamic determination of inhibition of PI3k signaling
Time frame: Cycle 1 Day 15
Pharmacodynamic determination modulation of Wnt pathway
Time frame: Cycle 1 Day 15
Pharmacodynamic determination modulation of Wnt pathway
Time frame: Cycle 1 Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
Related trials for Triple Negative Breast Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
RecruitingPhase 2
Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of TNBC
Breast Cancer Recurrent
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy Miller, MD principal investigator
Indiana University
Milan Radovich, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gedatolisib and PTK7-ADC in people with Triple Negative Breast Cancer and Metastatic Breast Cancer, run by Kathy Miller at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0 (time frame: through study completion i.e. up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.