A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patien… (NCT02109016) | Clinical Trial Compass
TerminatedPhase 2
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
United States18 participantsStarted 2014-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Screening, every 8 weeks; up to 2 years