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CancerPhase 2NCT02846766

Study of Lenvatinib in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling

A Phase 2 study testing Lenvatinib in people with Cancer, run by Teresa Helsten, MD at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a two center, open label, non-randomized Phase II study of lenvatinib in adult subjects with recurrent or refractory advanced cancers with aberration(s) in FGF/FGFR signaling. Treatment will consist of daily oral administration of Lenvatinib in 28-day cycles. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
1 Jul 2018to 1 Jun 2021
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

  • Age >= 18 years old
  • 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.
  • Evaluable tumor(s) with documented alteration(s) in FGF/FGFR-related gene(s). The FGF/FGFR aberration(s) can be identified at any point in the subject's cancer course. FGF/FGFR testing must have been performed in a CLIA-certified laboratory. Amplification(s) and/or mutation frequenc(ies) will be defined according to the standard of the test used. One example, Foundation OneTM, defines amplifications as ≥ 6 copies and base substitution mutations as present if there is ≥ 5% mutant allele frequency.
  • Subjects must meet the following laboratory requirements at screening (may be repeated): 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 Upper Limit of Normal (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 at screening (may be repeated and may be controlled with anti-hypertensive medication).
  • Adequate performance status (PS): Eastern Cooperative Oncology Group (ECOG) PS 0-2
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  • Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study and for at least 30 days after discontinuation of study drug (the half life of lenvatinib is about 28 hours in patients with cancer).
  • 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 (for example for breast or prostate cancer) and anti-Her2 therapies (for example, trastuzumab or lapatinib) are allowed to continue while on this study.
  • Subjects may not be receiving any other experimental agents or agents that are not FDA approved.
  • Ability to understand and willingness to sign a written consent document.

Who cannot join

  • Pregnant or lactating women.
  • Subjects with known hypersensitivity to any of the components or metabolites of the drug product.
  • Subjects with FGFR mutations known to be inactivating. Mutations of unknown significance (based on most currently available information) will be allowed.
  • 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 4.0 (CTCAE v4.0).
  • Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening.
  • Inability to swallow pills or determination by the investigator that absorption of oral medication would be impaired.
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  • Major surgery (not including placement of central lines) within 3 weeks prior to randomization or planned surgery during the course of this study.
  • Any medical condition which, in the opinion of the investigator, would preclude study participation.
  • Subjects who are considered members of a vulnerable population (for example, prisoners).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • University of California, San Diego

    La Jolla, California, 92093

Other trials in United States

About this study

Official title: A Multicenter, Histology-Independent Study of the Fibroblast Growth Factor Receptor (FGFR) Inhibitor Lenvatinib (E7080) in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling

This is a two center, open label, non-randomized Phase II study of lenvatinib in adult subjects with recurrent or refractory advanced cancers with aberration(s) in FGF/FGFR signaling. Treatment will consist of daily oral administration of Lenvatinib in 28-day cycles.

Read the detailed description

This exploratory, histology-independent study will enroll up to 39 subjects regardless of FGF/FGFR aberration or cancer type in order to test the hypothesis that subjects with advanced cancers harboring changes in FGF/FGFR-related genes will respond to the multikinase inhibitor lenvatinib at a higher rate than unselected cancer patients, regardless of the tumor histological subtype.

Lenvatinib is a multikinase inhibitor that inhibits FGFR1-4 as well as VEGFR1-3, RET, KIT and PDGFR-beta. It inhibits FGFR1 with an IC50 of 46 nmol/L, which is highly potent at a clinically relevant concentration.

Fibroblast growth factor (FGF) and FGF receptor (FGFR) pathway aberrations are common in malignancy, making this pathway a potentially appealing target for anti-cancer therapy. Clinical trial data suggest that targeting FGFR is indeed effective in cancer. However, the majority of such data come from trials in patient populations unselected for FGF/FGFR pathway abnormalities. The true response rates or clinical benefits for those whose cancers harbor FGF/FGFR abnormalities may be higher than observed in unselected patient populations.

Conditions
Cancer
Being tested
Lenvatinib
Keywords
advanced cancer, FGF, FGFR, Fibroblast Growth Factor Receptor
Medical subject headings
Neoplasms, Acrocephalosyndactylia

What participants receive

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

  • LenvatinibDrug

    Also called E7080, LENVIMA

    Lenvatinib is administered orally at a starting dose of 24 mg per day. Lenvatinib is administered in cycles of 28 days.

Study groups in NCT02846766
Study groupRoleWhat they receive
LenvatinibExperimentalThe starting dose of lenvatinib will be 24 mg orally per day. The duration of one cycle is defined as 28 days (4 weeks). Subjects will be treated for 2 cycles (8 weeks) and then restaged. Subjects will continue study drug until progression or unacceptable toxicity occurs.
Receives: Drug: Lenvatinib

What is being measured

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

  1. Objective Response Rates

    Measured: 2 months

Secondary outcomes (2)

  1. Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease greater than 6 months)

    Measured: 6 months

  2. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0

    Adverse events will be evaluated to determine:

    • duration (start and end dates)
    • severity (grade)
    • seriousness
    • relationship to study agent
    • action taken (i.e., none, study agent modification, medical intervention)
    • outcome (i.e., resolved without sequelae, resolved with sequelae, ongoing)

    Measured: 2 years

Timeline

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

  1. First posted27 Jul 2016 (estimated)
  2. Study start1 Jul 2018 (estimated)
  3. Primary completion1 Jun 2020 (estimated)
  4. Study completion1 Jun 2021 (estimated)

Why it stopped: Unable to execute a contract agreement with the drug manufacturer.

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
NCT02846766
Sponsor's protocol ID
150659
Status last verified
Jul 2018
First submitted
12 May 2016
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib in people with Cancer, run by Teresa Helsten, MD at 2 sites 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 10 inclusion and 9 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 2 sites 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?

Objective Response Rates (time frame: 2 months). 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 NCT02846766.

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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