Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations

Advanced Cancer Clinical Trial

Official title: Histology-Independent Study of the Multikinase Inhibitor Lucitanib (E3810) in Patients With Advanced Cancer and Fibroblast Growth Factor Receptor (FGFR), Vascular Endothelial Growth Factor Receptors (VEGFR), or Platelet Derived Growth Factor Receptor (PDGFR) Pathway Aberrations

Status Withdrawn

Clinical Trial Summary

Lucitanib is an oral multi kinase inhibitor designed to block the action of certain molecules called "angiogenic factors" that may cause tumors to grow. These factors are called vascular endothelial growth factor (VEGF), platelet derived growth factor receptor (PDGFR) and fibroblast growth factor (FGF). Lucitanib is experimental and not approved by the FDA for the treatment of cancer.

The purpose of this study is to look at the effects of lucitanib in cancer patients whose cancers harbor aberrations in FGFR, VEGFR, PDGFR or other markers predicted to be sensitive to lucitanib. This study will also look for biomarkers in samples of blood and tumor tissue to identify patients most likely to respond to lucitanib. Biomarkers are substances such as genetic material (DNA and RNA) and proteins found in blood and tumor tissue that might show if a cancer patient will respond or not respond to a drug.

Clinical Trial Description

Lucitanib is an oral multi kinase inhibitor designed to block the action of certain molecules called "angiogenic factors" that may cause tumors to grow. These factors are called vascular endothelial growth factor (called VEGF), platelet derived growth factor receptor (PDGFR) and fibroblast growth factor (called FGF). Lucitanib is experimental and not approved by the FDA for the treatment of cancer.

The purpose of this clinical trial is to study the following in cancer patients whose cancers harbor aberrations in FGFR, VEGFR, PDGFR, or other biomarkers predicted to be sensitive to lucitanib:

• To look at the effects of lucitanib on their disease at 10 mg once daily.

• To look for biomarkers in samples of blood and tumor tissue to identify patients most likely to respond to lucitanib.

• To look at the safety of lucitanib in these patients

This is a two-center, open-label, non-randomized Phase II study of lucitanib in adult subjects with advanced cancers. Treatment will consist of daily oral administration of 10mg of lucitanib in 28-day cycles.

All patients providing informed consent will be screened for eligibility. Baseline assessments will include vital signs, physical exam, blood hematology and chemistries, ECG, and ECHO. If not done within the prior 4 weeks, a PET/CT scan, MRI, and/or CT scan will be performed for radiological evaluation of disease.

Clinical evaluations include physical exam, vitals, ECG (obtained once every month throughout treatment); blood hematology and chemistries (obtained every two weeks for the first three months and then once every month throughout treatment); radiologic evaluations (PET/CT, CT and/or MRI, +/- bone imaging as clinically appropriate) will be performed every 8 weeks.

This study may last up to approximately 4 years or longer, depending on whether or not the study doctor feels that continuing lucitanib dosing is in the patient's best interest. Once a patient finishes study treatment with lucitanib, patients will need to complete an End of Study visit. Each of the study visits can last from approximately 2 to 8 hours. ;

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

• NCT number: NCT02747797
• Study type: Interventional
• Source: University of California, San Diego
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2017
• Completion date: April 2022