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

• Status: Terminated
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.

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