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Advanced CancerPhase 2NCT02747797

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

A Phase 2 study testing Lucitanib in people with Advanced Cancer, run by Teresa Helsten, MD at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
Lucitanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2017to Apr 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
  • Subject is intolerant of standard therapy
  • Malignancy is refractory to standard therapy
  • Malignancy relapsed after standard therapy
  • Malignancy for which there is no standard therapy that improves survival by at least 3 months.
  • Subjects must have evaluable tumor(s) with documented alteration(s) in potential lucitanib related biomarker(s) VEGFR, FGFR, PDGFR.
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  • Laboratory function within specified parameters:
  • Adequate bone marrow function: absolute neutrophil count ≥ 1,500/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 75,000/mL.
  • Adequate liver function: transaminases (AST/ALT) and alkaline phosphatase ≤ 3 (≤ 5 X ULN in the setting of liver metastasis) x ULN; bilirubin ≤ 1.5 x ULN.
  • Adequate renal function: creatinine clearance ≥ 40 mL/min (Cockcroft Gault).
  • Adequate blood coagulation: international normalized ratio (INR) ≤ 2.3.
  • Serum amylase and lipase ≤ 1.5 x ULN.
  • Adequately controlled blood pressure (BP): BP ≤ 150/90 mm Hg. Use of > 2 antihypertensive agents at enrollment is not allowed.
  • Adequate performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
  • Subjects must be off other anti-tumor agents for at least 5 half lives of the agent or 4 weeks from the last day of treatment, whichever is shorter. Endocrine therapies (e.g., for breast or prostate cancer) and anti-Her2 therapies (for example, trastuzumab, pertuzumab, or lapatinib) are allowed to continue while on this study. Bisphosphonates or denosumab are allowed for subjects with bone metastasis.
  • Subjects may not be receiving any other experimental agents or agents that are not FDA approved.

Who cannot join

  • Pregnant or lactating women.
  • Uncontrolled hypertension (defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized antihypertensive therapy)
  • Subjects who have not recovered from toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as < Grade 2 severity per Common Terminology Criteria for Adverse Events Version 4.3.
  • Significant cardiovascular impairment: history of CHF greater than New York Heart Association (NYHA) Class II, unstable angina, MI or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment.
  • Uncontrolled hypothyroidism defined as serum TSH higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy.
  • Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic INR monitoring, e.g., warfarin or similar agents. Treatment with LMWH and factor X inhibitors that do not require INR monitoring is permitted. Anti-platelet agents are prohibited throughout the study.
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  • Current treatment with any prohibited medications associated with prolongation of QT interval.
  • Received strong inhibitors of CYP2C8 or CYP3A4 or strong inducers of CYP3A4 ≤ 7 days prior to first dose of lucitanib or have on-going requirements for these medications.
  • Received bevacizumab < 3 months prior to first dose of lucitanib.
  • Major surgery (not including placement of central lines) within 3 weeks prior to study or planned surgery during the course of this study.
  • Subjects with breast or lung cancer who are eligible for other clinical trials of lucitanib open at their institution are not eligible for this trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Advanced Cancer
Being tested
Lucitanib
Keywords
Advanced Cancer, Lucitanib (E3810), Fibroblast Growth Factor Receptor, FGFR, Vascular Endothelial Growth Factor Receptor, VEGFR, Platelet Derived Growth Factor Receptor, PDGFR, metastatic malignancy
Medical subject headings
Acrocephalosyndactylia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LucitanibDrug

    Also called E3810

    10 mg orally daily

Study groups in NCT02747797
Study groupRoleWhat they receive
Advanced cancer with lucitanib-targeting biomarker(s)ExperimentalLucitanib 10 mg orally daily
Receives: Drug: Lucitanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rates to lucitanib in subjects with advanced cancers harboring aberrations targeted by lucitanib.

    Measured: 28-day cycle

Secondary outcomes (3)

  1. Clinical Benefit rates (complete response (CR), partial response (PR), or stable disease (SD) ≥ 6 months) in the study population.

    Clinical Benefit will be defined as SD ≥ 6 cycles and PR/CR of any duration.

    Measured: through study completion, up tp 3 years

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    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

    Measured: 28-day cycle

  3. Correlation between response rates and specific molecular tumor profile (type of FGF/FGFR or other aberration) in a descriptive fashion

    Measured: 28-day cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study startApr 2017 (estimated)
  3. Primary completionApr 2021 (estimated)
  4. Study completionApr 2022 (estimated)

Why it stopped: Drug Supply No Longer Available

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02747797
Sponsor's protocol ID
141506
Status last verified
Jul 2018
First submitted
22 Mar 2016
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lucitanib in people with Advanced Cancer, run by Teresa Helsten, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rates to lucitanib in subjects with advanced cancers harboring aberrations targeted by lucitanib. (time frame: 28-day cycle). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02747797.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.

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