NCT02915172

Brief 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. 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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

6 years

First QC Date

September 23, 2016

Last Update Submit

June 23, 2017

Conditions

Advanced CancerMalignant Neoplasm of BreastMalignant Neoplasms of Bone and Articular CartilageMalignant Neoplasms of Digestive OrgansMalignant Neoplasms of Eye Brain and Other Parts of Central Nervous SystemMalignant Neoplasms of Female Genital OrgansMalignant Neoplasms of Ill-defined Secondary and Unspecified SitesMalignant Neoplasms of Independent (Primary) Multiple SitesMalignant Neoplasms of Lip Oral Cavity and PharynxMalignant Neoplasms of Male Genital OrgansMalignant Neoplasms of Mesothelial and Soft TissueMalignant Neoplasms of Respiratory and Intrathoracic OrgansMalignant Neoplasms of Thyroid and Other Endocrine GlandsMalignant Neoplasms of Urinary Tract

Keywords

Advanced CancerMalignant neoplasm of breastMalignant neoplasms of bone and articular cartilageMalignant neoplasms of digestive organsMalignant neoplasms of eye brain and other parts of central nervous systemMalignant neoplasms of female genital organsMalignant neoplasms of ill-defined secondary and unspecified sitesMalignant neoplasms of independent (primary) multiple sitesMalignant neoplasms of lip oral cavity and pharynxMalignant neoplasms of male genital organsMalignant neoplasms of mesothelial and soft tissueMalignant neoplasms of respiratory and intrathoracic organsMalignant neoplasms of thyroid and other endocrine glandsMalignant neoplasms of urinary tractLenvatinibE7080LenvimaCapecitabineXeloda

Outcome Measures

Primary Outcomes (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,

    3 weeks

Secondary Outcomes (1)

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

    42 days

Study Arms (1)

Lenvatinib + Capecitabine

EXPERIMENTAL

Phase 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.

Drug: LenvatinibDrug: Capecitabine

Interventions

LenvatinibDRUG

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.

Also known as: E7080, Lenvima
Lenvatinib + Capecitabine
CapecitabineDRUG

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.

Also known as: Xeloda
Lenvatinib + Capecitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast NeoplasmsUrologic Neoplasms

Interventions

lenvatinibCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • David S. Hong, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 26, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2022

Last Updated

June 26, 2017

Record last verified: 2017-06