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CRIZENT: Crizotinib and Sunitinib in Metastatic Breast Cancer

NCT02074878 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-08-09

No results posted yet for this study

Summary

This is a Phase 1 Trial. Crizotinib is a medication that is taken by mouth. It has shown that it can help slow down or stop the growth of tumor cells. The marketing name of the drug is "Xalkori". It has been approved by the FDA (Food and Drug Administration) to treat other types of metastatic cancer, but the investigators believe it may be helpful to treat breast cancer as well.

Sunitinib is the other medication used in the study. It is also taken by mouth in the form of a capsule. The marketing name of this drug is "Sutent". It too has been approved by the FDA to treat other types of cancer, but not for breast cancer.

In this study the investigators will be combining both of these two treatments, but at different doses.

One third of the patients will take Crizotinib 200 mg, twice daily with Sunitinib 25.0 mg once a day.

One third of the patients will take Crizotinib 250 mg, twice daily with Sunitinib 25.0 mg once a day, and One third of the patients will take Crizotinib 250 mg, twice daily with Sunitinib 37.5 mg once a day.

Conditions

Interventions

DRUG

Crixotinib 200 mg and Sunitinib Cohort 1

Crizotinib 200 mg, twice daily with Sunitinib 25.0 mg once a day

DRUG

Crixotinib 250 mg and Sunitinib Cohort 2

Crizotinib 250 mg, twice daily with Sunitinib 25.0 mg once a day

DRUG

Crizotinib & Sunitinib 37.5 mg Cohort 3

Crizotinib 250 mg, twice daily with Sunitinib 37.5 mg once a day

Sponsors & Collaborators

  • Mothaffar Rimawi

    lead OTHER

Principal Investigators

  • Mothaffar Rimawi, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-05-16
Completion
2017-05-16

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02074878 on ClinicalTrials.gov