MedTrace Logo

Lenvatinib and Capecitabine in Patients With Advanced Malignancies

NCT02915172 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-06-26

No results posted yet for this study

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.

Conditions

  • 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

Interventions

DRUG

Lenvatinib

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.

DRUG

Capecitabine

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.

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David S. Hong, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2022-12-31
FDA Drug
Yes

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02915172 on ClinicalTrials.gov