Terminated
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 AdvancedMetastatic 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
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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
Brief 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
Eligibility Criteria
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
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