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Breast CancerPhase 1CRIZENTNCT02074878

CRIZENT: Crizotinib and Sunitinib in Metastatic Breast Cancer

A Phase 1 study testing Crixotinib 200 mg and Sunitinib Cohort 1, Crixotinib 250 mg and Sunitinib Cohort 2 and Crizotinib & Sunitinib 37.5 mg Cohort 3 in people with Breast Cancer, run by Mothaffar Rimawi at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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". Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Crixotinib 200 mg and Sunitinib Cohort 1, Crixotinib 250 mg and Sunitinib Cohort 2 and Crizotinib & Sunitinib 37.5 mg Cohort 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Jun 2014to 16 May 2017
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

  • Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up.
  • Age of at least 18 years
  • Histologically confirmed diagnosis of stage IV, HER2 negative breast cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Patients must have failed two lines of systemic therapy for breast cancer. Patients who are hormone receptor positive must have failed at least one line of hormonal therapy AND one line of chemotherapy in the metastatic setting.
  • Life expectancy of 6 months or more.
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  • Liver function (ALT, AST, alkaline phosphatase, total bilirubin) and kidney function tests (BUN, creatinine) less than 2.5 times the upper limit of normal. In patients with liver metastasis, liver function tests should be less than 5 times the upper limit of normal.
  • Adequate blood counts (Hemoglobin greater than/equal to 10, WBC greater than/equal to 3.0, platelets greater than/equal to 100).
  • The patient has normal thyroid function tests (TSH, free T4) as defined by the testing laboratory, a test abnormality that is asymptomatic and does not warrant medical intervention, or a pre-existing thyroid disorder that is controlled on medical treatment.
  • Negative pregnancy test (BHCG) within 14 days of study drug initiation for pre- or perimenopausal subjects with an intact uterus.

Who cannot join

  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational products.
  • Presence of uncontrolled infection.
  • Corrected QT interval (QTc) > 480 msecs using Bazett's formula
  • History of any one or more of the following cardiovascular conditions within the past 6 months: - Cardiac angioplasty or stenting - Myocardial infarction - Unstable angina - Coronary artery bypass graft surgery - Symptomatic peripheral vascular disease - Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  • Poorly controlled hypertension (defined as systolic blood pressure [SBP] of > 150 mmHg or diastolic blood pressure [DBP] of > 90 mmHg).
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  • History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months. Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major).
  • Evidence of active bleeding or bleeding diathesis.
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
  • Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks prior to first dose of study drug.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
  • Patients previously treated with sunitinib or crizotinib.
  • History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin.
  • Concurrent use of: - Potent CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and voriconazole. - CYP3A4 inducers: rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamazepine, St. John's Wort, and dexamethasone. Use of dexamethasone for study premedication is allowed. - Grapefruit and grapefruit juice. (Note: Alternative therapies should be used when available. If use of a potent CYP3A4 inhibitor or inducer is necessary, this must be approved by the principal investigator and documented in source documents).
  • History of receiving any investigational treatment within 28 days of study medication initiation.
  • Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, thyroid, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
  • Patients who are pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lester and Sue Smith Breast Center, Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase IB Study of Crizotinib (XALKORI) and Sunitinib (SUTENT) in Metastatic Breast Cancer

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.

Read more

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.

Read the detailed description

This study will determine the safety and tolerability of the combination of crizotinib and sunitinib in the treatment of Metastatic Breast Cancer and help to establish the maximum tolerated dose for future phase II studies of the combination.

Conditions
Breast Cancer
Being tested
Crixotinib 200 mg and Sunitinib Cohort 1, Crixotinib 250 mg and Sunitinib Cohort 2, Crizotinib & Sunitinib 37.5 mg Cohort 3
Keywords
Breast Cancer, Metastatic, Crizotinib, Sunitinib, Xalcori, Sutent
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • Crixotinib 200 mg and Sunitinib Cohort 1Drug

    Also called Crizotinib (Xalkori) 200 mg twice daily, Sunitinib (Sutent) 25.0 mg once a day

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

  • Crixotinib 250 mg and Sunitinib Cohort 2Drug

    Also called Crixotinib (Xalkori) 250, Sunitinib (Sutent) 25.0

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

  • Crizotinib & Sunitinib 37.5 mg Cohort 3Drug

    Also called Crizotinib (Xalkori) 250 mg, Sunitinib (Sutent) 37.5 mg

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

Study groups in NCT02074878
Study groupRoleWhat they receive
Crixotinib 200 mg and Sunitinib Cohort 1ExperimentalCrizotinib 200mg, twice daily and Sunitinib 25.0mg once daily
Receives: Drug: Crixotinib 200 mg and Sunitinib Cohort 1
Crixotinib 250 mg and Sunitinib Cohort 2ExperimentalCrizotinib 250 mg, twice daily with Sunitinib 25.0 mg once a day
Receives: Drug: Crixotinib 250 mg and Sunitinib Cohort 2
Crizotinib & Sunitinib 37.5 mg Cohort 3ExperimentalCrizotinib 250 mg, twice daily with Sunitinib 37.5 mg once a day
Receives: Drug: Crizotinib & Sunitinib 37.5 mg Cohort 3

What is being measured

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

  1. Maximum tolerated dose of the treatment drugs in the patients that are taking it.

    To determine the tolerability of the combination of crizotinib and sunitinib in the treatment of women with metastatic breast cancer (MBC). - This is done by identifying the maximum tolerated dose (MTD) for future phase II studies of the combination of crizotinib and sunitinib.

    Measured: 1 year

Secondary outcomes (2)

  1. Changes that occur in tumor tissue before treatment and after treatment.

    Assess the clinical activity of the combination regimen in patients with MBC. - This is done by performing exploratory correlative studies on tissue acquired from accessible metastatic lesions based on serial biopsies performed at baseline and recording changes in biomarker levels between responders vs. non-responders.

    Measured: 2 years

  2. Laboratory results to make sure the treatment is safe.

    Safety and toxicity parameters will be summarized using descriptive statistics. All patients who received any amount of study drugs will be included in the safety analysis. Safety analyses will include summaries of adverse event rates (both frequency and incidence tables), baseline laboratory parameters and changes from baseline, frequency of CTCAE toxicity grades for both laboratory and non-laboratory data.

    Measured: 1 year

Timeline

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

  1. First posted28 Feb 2014 (estimated)
  2. Study startJun 2014
  3. Primary completion16 May 2017
  4. Study completion16 May 2017

Why it stopped: Poor accrual so the study was halted on May 16, 2017.

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02074878
Sponsor's protocol ID
H-33624
Acronym
CRIZENT
Status last verified
Aug 2017
First submitted
17 Dec 2013
Last updated
9 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Crixotinib 200 mg and Sunitinib Cohort 1, Crixotinib 250 mg and Sunitinib Cohort 2 and Crizotinib & Sunitinib 37.5 mg Cohort 3 in people with Breast Cancer, run by Mothaffar Rimawi at 1 site 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 18 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: stopped early, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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 stopped early (reason given: Poor accrual so the study was halted on May 16, 2017.). Results are not available in the source record.

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 of the treatment drugs in the patients that are taking it. (time frame: 1 year). 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 NCT02074878.

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 9 Aug 2017.

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