Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer.
Mingxiang Liao, Jie Zhou, Kenton Wride...
https://pubmed.ncbi.nlm.nih.gov/35844029Terminated
Phase 2
Age: 18Years +
All Genders
ID02109016
A Single Arm, Open-label, Phase 2 Study to Assess the Efficacy and Safety of Lucitanib Given Orally as a Single Agent to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations
Led by Clovis Oncology, Inc. · Updated on 2019-07-29
18
Participants Needed
19
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations.
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
- Any of the following tumor tissue based genetic alterations: FGFR1, FGFR2, FGFR3, VEGFA, or PDGFRα amplification; Any FGFR1, FGFR2, or FGFR3 gene fusion; FGFR1, FGFR2, or FGFR3 activating mutation
- Availability of tumor tissue sample suitable for the central confirmation of the genetic alteration and exploratory analyses
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- Measurable disease per RECIST 1.1
- Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
You will not qualify if you...
- Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
- Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive therapy
- Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
- Symptomatic and/or untreated central nervous system metastases
- Presence of another active cancer
- Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
- Pregnant or breastfeeding women
Trial Site Locations
Total: 19 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Status Unknown
2
University of Colorado
Aurora, Colorado, United States, 80045
Status Unknown
3
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Status Unknown
4
Emory University
Atlanta, Georgia, United States, 30322
Status Unknown
5
Associates in Oncology and Hematology
Rockville, Maryland, United States, 20850
Status Unknown
6
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Status Unknown
7
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Status Unknown
8
CHU Caen, Hôpital de la Côte de Nacre
Caen, France, 14033
Status Unknown
9
CHRU Lille, Hôpital Albert Calmette
Lille, France, 59037
Status Unknown
10
Hôpital Nord
Marseille, France, 13915
Status Unknown
11
Institut Gustave-Roussy
Villejuif, France, 94805
Status Unknown
12
Universität Duisburg-Essen
Essen, Germany, 45147
Status Unknown
13
Hospital Grosshansdorf
Großhansdorf, Germany, 22927
Status Unknown
14
Pius Hospital Oldenburg
Oldenburg, Germany, 26121
Status Unknown
15
Ospedale San Raffaele
Milan, Italy, 20132
Status Unknown
16
Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy, 20133
Status Unknown
17
AOU San Luigi Gonzaga
Orbassano, Italy, 10043
Status Unknown
18
Ospedale S. Maria della Misericordia
Perugia, Italy, 06156
Status Unknown
19
Hospital Universitari Vall d'Hebrón
Barcelona, Catalonia, Spain, 8035
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here