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
NCT ID: NCT02684032
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
141 participants
INTERVENTIONAL
2016-06-14
2022-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Letrozole Cohort
Letrozole combination cohort in dose escalation
Gedatolisib
Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
Palbociclib
Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
Letrozole
Letrozole at 2.5 mg daily
Fulvestrant cohort
Fulvestrant combination cohort in dose escalation
Gedatolisib
Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
Palbociclib
Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
Fulvestrant
Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.
ARM A
Gedatolisib + palbociclib + letrozole in dose expansion
Gedatolisib
Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
Palbociclib
Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
Letrozole
Letrozole at 2.5 mg daily
ARM B
Gedatolisib + palbociclib + fulvestrant in dose expansion
Gedatolisib
Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
Palbociclib
Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
Fulvestrant
Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.
ARM C
Gedatolisib + palbociclib + fulvestrant in dose expansion
Gedatolisib
Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
Palbociclib
Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
Fulvestrant
Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.
Arm D
Gedatolisib (3:1) + palbociclib + fulvestrant in dose expansion
Fulvestrant
Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.
Interventions
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Gedatolisib
Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
Palbociclib
Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
Letrozole
Letrozole at 2.5 mg daily
Fulvestrant
Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically proven diagnosis of breast cancer with evidence of metastasis.
* Documentation of estrogen receptor positive ((ER+), human epidermal growth factor receptor 2 (HER2 negative (HER2-)) tumor.
* Dose Escalation Portion: Patients must satisfy one of the following criteria:
* Letrozole combination cohort (L): metastatic breast cancer (MBC) with progression who are candidates for a letrozole-containing regimen, with palbociclib.
* Fulvestrant combination cohort (F): MBC with progression who are candidates for a fulvestrant containing regimen, with palbociclib.
* Dose Expansion Portion: Patients must satisfy one of the following criteria:
* Arm A: MBC with progression and no prior endocrine based systemic therapy in the metastatic setting;
* Arm B: MBC with progression during or following one prior endocrine based systemic therapy in the metastatic setting, with no prior therapy with any cyclin-dependent kinase (CDK) inhibitor;
* Arm C/Arm D: MBC with progression during or following one or two prior endocrine based systemic therapies in the metastatic setting, and following prior therapy with a CDK inhibitor.
* Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
* Bone only patients during dose escalation portion.
* Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.
* Eastern Cooperative Oncology Group \[ECOG\] performance must be 0 or 1.
* Adequate bone marrow, renal and liver function.
Exclusion Criteria
* More than 1 line of prior chemotherapy in the treatment of metastatic or locally advanced/recurrent disease.
* Bone only patients during expansion/efficacy portion.
* Patients with advanced/metastatic disease who have symptomatic visceral spread, and who have life threatening complications needing immediate therapy, such as massive uncontrolled effusions \[pleural, pericardial, peritoneal\], pulmonary lymphangitis, and over 50% liver replacement with tumor.
* Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases.
* Active bacterial, fungal or viral infection.
* Uncontrolled or significant cardiovascular disease.
* Radiation therapy within 4 weeks of investigational product.
* Cytotoxic chemotherapy within 4 weeks of investigational product (6 weeks for mitomycin C or nitrosoureas) if immediate prior regimen was administered on an every 3 4 week schedule or 2 weeks of investigational product if immediate prior regimen consisted of weekly therapy.
* Any other anti cancer agents (eg, hormonal, biological, investigational) within 5 times the half life prior to investigational product.
* Impairment of gastro intestinal (GI) function or GI disease.
* Pregnant female patients; breastfeeding female patients; and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for 90 days.
18 Years
FEMALE
No
Sponsors
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Celcuity Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Igor Gorbatchevsky, MD
Role: STUDY_DIRECTOR
Celcuity Inc
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States
Keck Hospital of USC - Norris Healthcare Center (HC3)
Los Angeles, California, United States
Keck Hospital of USC
Los Angeles, California, United States
LAC+USC Medical Center
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.
Riverside, California, United States
UCSF - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
UCSF - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AiP)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, United States
University of Colorado Hospital - Clinical Trials Office (CTO)
Aurora, Colorado, United States
University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States
Moffitt Cancer Center Richard M Schulze Family Foundation Outpatient Center at McKinley Campus
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
The Emory Clinic
Atlanta, Georgia, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Karmanos Cancer Institute
Farmington Hills, Michigan, United States
UNC Cancer Hospital Infusion Pharmacy
Chapel Hill, North Carolina, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, United States
Stefanie Spielman Comprehensive Breast Cancer
Columbus, Ohio, United States
Thomas Jefferson University - Clinical and Regulatory
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
U.T. MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Seattle Cancer Care Alliance (SCCA) Investigational Drug Services
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Layman RM, Han HS, Rugo HS, Stringer-Reasor EM, Specht JM, Dees EC, Kabos P, Suzuki S, Mutka SC, Sullivan BF, Gorbatchevsky I, Wesolowski R. Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. Lancet Oncol. 2024 Apr;25(4):474-487. doi: 10.1016/S1470-2045(24)00034-2.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2151009
Identifier Type: -
Identifier Source: org_study_id
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