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Poor accrual so the study was halted on May 16, 2017.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crixotinib 200 mg and Sunitinib Cohort 1 | Experimental | Crizotinib 200mg, twice daily and Sunitinib 25.0mg once daily |
|
| Crixotinib 250 mg and Sunitinib Cohort 2 | Experimental | Crizotinib 250 mg, twice daily with Sunitinib 25.0 mg once a day |
|
| Crizotinib & Sunitinib 37.5 mg Cohort 3 | Experimental | Crizotinib 250 mg, twice daily with Sunitinib 37.5 mg once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crixotinib 200 mg and Sunitinib Cohort 1 | Drug | Crizotinib 200 mg, twice daily with Sunitinib 25.0 mg once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mothaffar Rimawi, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lester and Sue Smith Breast Center, Baylor College of Medicine | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
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| Crixotinib 250 mg and Sunitinib Cohort 2 | Drug | Crizotinib 250 mg, twice daily with Sunitinib 25.0 mg once a day |
|
|
| Crizotinib & Sunitinib 37.5 mg Cohort 3 | Drug | Crizotinib 250 mg, twice daily with Sunitinib 37.5 mg once a day |
|
|
| 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. | 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |