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Advanced CancerPhase 1NCT02915172

Lenvatinib and Capecitabine in Patients With Advanced Malignancies

A Phase 1 study testing Lenvatinib and Capecitabine in people with Advanced Cancer and Malignant Neoplasm of Breast, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenvatinib and Xeloda (capecitabine) that can be given to patients with advanced cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lenvatinib and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2016to Dec 2022
Phase
Phase 1
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

  • Patients with a histologically and/or cytologically confirmed solid tumor who are resistant / refractory to approved therapies or for whom no curative therapies are available.
  • All previous treatment (including surgery, radiotherapy and systemic anti-neoplastic therapy) must have been completed at least three weeks prior to study entry and any acute toxicities must have resolved.
  • Aged >/= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of </= 2.
  • Written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
  • Willing and able to comply with the protocol guidelines for the duration of the study.

Who cannot join

  • Unstable metastases to the central nervous system (CNS).
  • Any of the following laboratory parameters: a) hemoglobin < 9 g/dL (5.6 mmol/L); b) neutrophils <1.5 x 109/L; c) platelets <100 x 109/L; d) serum bilirubin >25 µmol/L (1.5 mg/dL); e) liver function tests with values >3 x upper limit of normal (ULN) f) serum creatinine >1.5 x ULN or creatinine clearance < 60 mL/minute
  • Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection
  • Centrally located non-small cell lung cancers and squamous cell lung cancers
  • Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
  • Patients with marked Baseline prolongation of QT/QTc interval (QTc interval > 450 msec for males or > 470 msec for females) using the Fridericia method for QTc analysis
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  • Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants, such as warfarin. Occasional use of NSAIDs and antiplatelet agents such as aspirin, clopidogrel, aggrenox and dipyridamole are not considered exclusionary if taken <7 days per 28 days. However, if the patient requires chronic use (>/=7 days out of 28 days) of full doses of aspirin or NSAIDs then the patient is excluded.
  • Requirement for chronic use of full dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Poorly controlled hypertension (defined as requiring changes in any hypertensive regimen within 1 week of study entry) or patients diagnosed with hypertension based on repeat blood pressure measurements of >160/90 mmHg at Screening
  • Proteinuria > 1+ on urine dipstick testing or 30 mg/dL
  • A history of gastrointestinal malabsorption or having undergone surgery requiring gastrointestinal anastomoses within four weeks of starting therapy or who have not recovered from major surgery within three weeks of starting therapy
  • History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance.
  • Any treatment with investigational drugs within 30 days before the start of the study
  • Previous treatment with E7080
  • Women who are pregnant or breast-feeding; women of childbearing potential with a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception (including two forms of contraception, one of which must be a barrier method) in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Fertile males with female partners who are not willing to use contraception or whose female partners are not using adequate contraceptive protection
  • Legal incapacity

About this study

Official title: A Phase I Trial of Lenvatinib (Multi-kinase Inhibitor) and Capecitabine (Anti-metabolite) in Patients With Advanced Malignancies

There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion).

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenvatinib and Xeloda (capecitabine) that can be given to patients with advanced cancer. The goal of Phase 2 of this study is to learn if the dose of lenvatinib and capecitabine found in Phase 1 can help to control advanced cancer.

The safety of this drug combination will be studied in both phases of the study.

Read the detailed description

Study Groups:

If participant is are found to be eligible to take part in this study, they will be assigned to a study group based on when they join this study. Up to 4 groups of up to 18 participants will be enrolled in Phase 1 of the study, and up to 28 participants will be enrolled in Phase 2.

If participant is enrolled in Phase 1, the dose of lenvatinib they receive will depend on when they join this study. The first group of participants will receive the lowest dose level of lenvatinib. Each new group will receive a higher dose of lenvatinib than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of lenvatinib is found.

If participant is enrolled in Phase 2, they will receive lenvatinib at the highest dose that was tolerated in Phase 1.

All participants will receive the same dose of capecitabine.

Study Drug Administration:

Each study cycle is 21 days.

Participant will take lenvatinib by mouth every day and capecitabine by mouth 2 times every day.

Length of Study Participation:

Participant may continue taking the study drugs for as long as the doctor thinks it is in their best interest. Participant will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.

Patient's participation on the study will be over after the end-of-study visit (described below).

Study Visits:

During Week 2 of Cycle 1:

  • Participant will have a physical exam.
  • Blood (about 3 teaspoons) will be drawn for routine tests.
  • If participant is enrolled in Phase 2, they will have a tumor biopsy for biomarker testing.
  • If participant is enrolled in Phase 2, blood (about 2 teaspoons) will be drawn for biomarker, CTC, and cfDNA testing.

During Week 3 of Cycle 1, blood (about 3 teaspoons) will be drawn for routine tests.

During Week 1 of Cycles 2 and beyond:

  • Participant will have a physical exam.
  • Blood (about 3 teaspoons) will be drawn for routine tests.
  • If participant is enrolled in Phase 2, blood (about 2 teaspoons) will be drawn for biomarker, CTC, and cfDNA testing.
  • If participant can become pregnant, blood (about 1 teaspoon) will be collected for a pregnancy test.

During Weeks 2 and 3 of Cycles 2 and beyond, participant will be called by a member of the study staff and asked about any side effects they may have. This call should last about 5-10 minutes.

During Week 3 of Cycle 2 and then every even-numbered cycle after that (Cycles 4, 6, 8, and so on), participant will have a CT scan or MRI.

End-of-Study Visit:

After participant's last dose of study drug, they will have an end-of-study visit. At this visit, the following tests and procedures will be performed:

  • Participant will have a physical exam.
  • Blood (about 3 teaspoons) will be drawn for routine tests.
  • Participant will have a CT scan or MRI to check the status of the disease.
  • If participant can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
  • If participant is enrolled in Phase 2, blood (about 2 teaspoons) will be drawn for biomarker, CTC, and cfDNA testing.

This is an investigational study. Lenvatinib is FDA approved and commercially available for the treatment of certain types of thyroid cancer. Capecitabine is FDA approved and commercially available for the treatment of certain types of breast and colorectal cancers. It is considered investigational to use lenvatinib and capecitabine to treat advanced cancer.

The study doctor can explain how the study drugs are designed to work.

Up to 46 participants will be enrolled in this study. All will take part at MD Anderson.

Keywords
Advanced Cancer, Malignant neoplasm of breast, Malignant neoplasms of bone and articular cartilage, Malignant neoplasms of digestive organs, Malignant neoplasms of eye brain and other parts of central nervous system, Malignant neoplasms of female genital organs, Malignant neoplasms of ill-defined secondary and unspecified sites, Malignant neoplasms of independent (primary) multiple sites, Malignant neoplasms of lip oral cavity and pharynx, Malignant neoplasms of male genital organs, Malignant neoplasms of mesothelial and soft tissue, Malignant neoplasms of respiratory and intrathoracic organs, Malignant neoplasms of thyroid and other endocrine glands, Malignant neoplasms of urinary tract, Lenvatinib, E7080, Lenvima, Capecitabine, Xeloda
Medical subject headings
Breast Neoplasms, Urologic Neoplasms

What participants receive

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

  • LenvatinibDrug

    Also called E7080, Lenvima

    Phase 1 Dose Escalation: Starting dose of Lenvatinib 10 mg by mouth once daily of a 21 day cycle.

    Phase 2 Dose Expansion: Starting dose of Lenvatinib is maximum tolerated dose from Phase 1.

  • CapecitabineDrug

    Also called Xeloda

    Phase 1 Dose Escalation and Phase 2 Dose Expansion: Capecitabine 1000 mg/m2 twice daily by mouth on Days 1 - 14 of a 21 day cycle.

Study groups in NCT02915172
Study groupRoleWhat they receive
Lenvatinib + CapecitabineExperimentalPhase 1 Study Escalation: Group consists of participants with various solid tumors. Dose of Lenvatinib received depends on when joining study. First group of participants receive lowest dose level of Lenvatinib. Each new group receives a higher dose of Lenvatinib than the group before it, if no intolerable side effects were seen. This continues until highest tolerable dose of Lenvatinib found. All participants receive the same dose of Capecitabine. Phase 2 Study Expansion: Group consists of participants with advanced breast cancer and any solid tumors with confirmed FGFR abnormalities. Participants receive Lenvatinib at the highest dose that was tolerated in Dose Escalation Phase. All participants receive the same dose of Capecitabine.
Receives: Drug: Lenvatinib; Drug: Capecitabine

What is being measured

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

  1. Maximum Tolerated Dose (MTD) of Combination Treatment with Lenvatinib and Capecitabine in Advanced and/or Metastatic Cancer Refractory to Standard Treatment

    MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any clinically grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v4.0,

    Measured: 3 weeks

Secondary outcomes (1)

  1. Antitumor Efficacy of Combination of Lenvatinib and Capecitabine in Breast Cancer and Solid Tumors with FGFR Abnormality

    Efficacy evaluation done using RECIST criteria version 1.1.

    Measured: 42 days

Timeline

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

  1. First posted26 Sep 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionDec 2022 (estimated)

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 1
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
NCT02915172
Sponsor's protocol ID
2016-0323
Status last verified
Jun 2017
First submitted
23 Sep 2016
Last updated
26 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenvatinib and Capecitabine in people with Advanced Cancer and Malignant Neoplasm of Breast, run by M.D. Anderson Cancer Center.

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 6 inclusion and 17 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 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Maximum Tolerated Dose (MTD) of Combination Treatment with Lenvatinib and Capecitabine in Advanced and/or Metastatic Cancer Refractory to Standard Treatment (time frame: 3 weeks). 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 NCT02915172.

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 26 Jun 2017.

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