Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations
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|ClinicalTrials.gov Identifier: NCT02747797|
Recruitment Status : Withdrawn (Drug Supply No Longer Available)
First Posted : April 22, 2016
Last Update Posted : August 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: Lucitanib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||April 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2022|
Experimental: Advanced cancer with lucitanib-targeting biomarker(s)
Lucitanib 10 mg orally daily
10 mg orally daily
Other Name: E3810
- Response rates to lucitanib in subjects with advanced cancers harboring aberrations targeted by lucitanib. [ Time Frame: 28-day cycle ]
- Clinical Benefit rates (complete response (CR), partial response (PR), or stable disease (SD) ≥ 6 months) in the study population. [ Time Frame: through study completion, up tp 3 years ]Clinical Benefit will be defined as SD ≥ 6 cycles and PR/CR of any duration.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 28-day cycle ]Toxicities will be described according to the NCI-CTCAE Version 4.3. Unacceptable toxicity is defined as any clinically significant Grade 3 or 4 toxicity including expected toxicities definitely, probably, or possibly related to the study medication that are not amenable to dose reduction
- Correlation between response rates and specific molecular tumor profile (type of FGF/FGFR or other aberration) in a descriptive fashion [ Time Frame: 28-day cycle ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747797
|United States, California|
|UC San Diego Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Teresa Helsten, MD||University of California, San Diego|