Study Stopped
Sponsor decision to end monotherapy development of the compound in breast cancer.
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients With FGF Aberrant Metastatic Breast Cancer
1 other identifier
interventional
178
1 country
33
Brief Summary
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Sep 2014
Shorter than P25 for phase_2 breast-cancer
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2014
CompletedFirst Posted
Study publicly available on registry
July 29, 2014
CompletedStudy Start
First participant enrolled
September 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2017
CompletedResults Posted
Study results publicly available
June 23, 2020
CompletedJune 23, 2020
June 1, 2020
2.4 years
July 25, 2014
February 20, 2020
June 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by the Investigator
The primary efficacy endpoint of PFS was calculated as 1+ the number of days from the date of first dose of study drug to disease progression or death due to any cause, whichever occurs first. Patients without a documented event of progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment), or the date of randomization if no tumor assessments were performed. Progression events were determined by the investigator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months
Secondary Outcomes (10)
Objective Response Rate (ORR) by RECIST v1.1
From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months
Duration of Response (DR) by RECIST v1.1
From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months
Disease Control Rate (DCR) by RECIST v1.1
From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months
Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Cmax
Study Day -7 to Study Day 1, or approximately 8 days
Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Tmax
Study Day -7 to Study Day 1, or approximately 8 days
- +5 more secondary outcomes
Study Arms (3)
Cohort A: Lucitanib (CO-3810) 10 mg daily
EXPERIMENTAL10 mg of lucitanib daily in patients with FGFR1-amplified or 11q-amplified metastatic breast cancer.
Cohort B: Lucitanib (CO-3810) 15 mg daily
EXPERIMENTAL15 mg of lucitanib daily in patients with FGFR1-amplified and 11q-amplified metastatic breast cancer.
Cohort C: Lucitanib (CO-3810) 10 mg daily
EXPERIMENTAL10 mg of lucitanib daily in patients with FGFR1 non-amplified and 11q non-amplified metastatic breast cancer.
Interventions
Lucitanib is a potent, orally available selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors (FGFR1-3), vascular endothelial growth factor receptors (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFR alpha and beta)
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment
- Prior treatment with standard first line therapy in the metastatic setting
- Availability of tumor tissue sufficient for confirmatory testing of FGFR1 and 11q amplification status
- Demonstrated progression of disease by radiological or clinical assessment (Measurable disease according to RECIST Version 1.1 is NOT required for enrollment)
- Estimated life expectancy \>6 months
You may not qualify if:
- Current or recent treatment with biologic anticancer therapies
- Ongoing AEs from prior anticancer therapies
- Active central nervous system (CNS) metastases
- Clinically significant or uncontrolled hypertension or cardiac disease
- Females who are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Arizona Oncology Associates
Sedona, Arizona, 86336, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Saint Jude Heritage Medical Center
Fullerton, California, 92835, United States
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
University of Southern California
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277, United States
University of California San Francisco
San Francisco, California, 94115, United States
Central Coast Medical Oncology Group
Santa Maria, California, 93454, United States
Yale University
New Haven, Connecticut, 06519, United States
University of Miami
Deerfield Beach, Florida, 33442, United States
Memorial West Cancer Center
Hollywood, Florida, 33021, United States
Northwestern University, Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Horizon Oncology Center
Lafayette, Indiana, 47905, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21231, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Cooper University Hospital
Voorhees Township, New Jersey, 08043, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Breast Center
New York, New York, 10065, United States
Sciode Medical Associates, PLLC
The Bronx, New York, 10469, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Texas Oncology - Austin Central
Austin, Texas, 78731, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
US Oncology
Houston, Texas, 77024, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Related Publications (1)
Liao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18.
PMID: 35844029DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Department
- Organization
- Clovis Oncology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2014
First Posted
July 29, 2014
Study Start
September 9, 2014
Primary Completion
January 17, 2017
Study Completion
January 18, 2017
Last Updated
June 23, 2020
Results First Posted
June 23, 2020
Record last verified: 2020-06