A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT02684032. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
PHASE 1B STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND CLINICAL ACTIVITY OF GEDATOLISIB IN COMBINATION WITH PALBOCICLIB AND EITHER LETROZOLE OR FULVESTRANT IN WOMEN WITH METASTATIC OR LOCALLY ADVANCED/RECURRENT BREAST CANCER (MBC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.
Study identification
- NCT ID
- NCT02684032
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 141 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 14, 2016 (Actual)
- Primary completion
- Jan 19, 2022 (Actual)
- Completion
- Jan 19, 2022 (Actual)
- Last update posted
- Jul 27, 2022
2016 – 2022
United States locations
- U.S. sites
- 41
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc. | Corona | California | 92879 | — |
| Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc. | Fountain Valley | California | 92708 | — |
| Keck Hospital of USC - Norris Healthcare Center (HC3) | Los Angeles | California | 90033 | — |
| Keck Hospital of USC | Los Angeles | California | 90033 | — |
| LAC+USC Medical Center | Los Angeles | California | 90033 | — |
| USC/Norris Comprehensive Cancer Center / Investigational Drug Services | Los Angeles | California | 90033 | — |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc. | Riverside | California | 92501 | — |
| UCSF - Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| UCSF - Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | — |
| University of Colorado Hospital - Anschutz Inpatient Pavilion (AiP) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Clinical Trials Office (CTO) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital- Anschutz Cancer Pavilion (ACP) | Aurora | Colorado | 80045 | — |
| Moffitt Cancer Center Richard M Schulze Family Foundation Outpatient Center at McKinley Campus | Tampa | Florida | 33612 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| The Emory Clinic | Atlanta | Georgia | 30322 | — |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Karmanos Cancer Institute | Farmington Hills | Michigan | 48334 | — |
| UNC Cancer Hospital Infusion Pharmacy | Chapel Hill | North Carolina | 27514 | — |
| UNC Hospitals, The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| The Ohio State University Wexner Medical Center James Cancer Hospital | Columbus | Ohio | 43210 | — |
| Stefanie Spielman Comprehensive Breast Cancer | Columbus | Ohio | 43212 | — |
| Thomas Jefferson University - Clinical and Regulatory | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Vanderbilt Breast Center at One Hundred Oaks | Nashville | Tennessee | 37204 | — |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| U.T. MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Seattle Cancer Care Alliance (SCCA) Investigational Drug Services | Seattle | Washington | 98109 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02684032, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02684032 live on ClinicalTrials.gov.