Sitravatinib in Metastatic Breast Cancer
Study Details
Study Description
Brief Summary
This study evaluates the efficacy of sitravatinib in patients with metastatic breast cancer. All study participants will receive sitravatinib, 120 mg daily, until their cancer worsens, or until they develop intolerable side effects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sitravatinib Sitravatinib 120 mg daily |
Drug: Sitravatinib
sitravatinib capsule
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Clinical Benefit Rate [24 weeks]
Clinical Benefit Rate is defined as Objective Response Rate (ORR) plus Stable Disease (SD) for 24 weeks as per Response Evaluation Criteria In Solid Tumours (RECIST) v1.1. ORR is defined Complete Response plus Partial Response per RECIST v1.1 criteria.
Secondary Outcome Measures
- Time to Progression [Up to 5 years]
Time to progression is calculated from Day 1 of sitravatinib therapy to first evidence of disease progression, as determine by Response Evaluation Criteria in Solid Tumors (RECIST).
- Number of patients with Grade 3 or higher adverse events [Up to 5 years]
Adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria version 5.0.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women or men age 18 and older
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Metastatic or locally advanced inoperable disease breast cancer
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Tumor is estrogen receptor (ER) negative and progesterone receptor (PR) negative per the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) Guidelines of 2010.
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Tumor is HER2neu negative per ASCO/CAP Guidelines of 2018
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Patient has tumor tissue blocks from metastatic or locally advanced breast cancer (beyond curative management) for the analysis of PTPN12 status
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Metastatic disease or locally advanced breast cancer (beyond curative management) that is measurable according to RECIST 1.1 criteria. Patients with bone only disease are eligible for enrollment if there is at least one lytic lesion that can be followed for response.
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At least one prior line of chemotherapy with or without a PDL1 or PD1 antibody in metastatic setting
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Patient has Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky
60%)
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Patients must have normal organ and marrow function as defined below:
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Absolute neutrophil count > 1000/mcL
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Hemoglobin > 11 g/dL
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Platelets >100,000/mcL
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Total bilirubin < 1.5 X normal institutional limits
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Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 2.5 X institutional upper limit of normal (ULN) or ≤ 5.0 × ULN for patients with documented liver metastases.
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Creatinine within normal institutional limits
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Creatinine clearance > 30 mL/min/1.73 m2
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Normal left ventricular ejection (LVEF) function defined as normal left ventricular wall motion and ejection fraction of ≥ 50%.
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If patient has brain metastasis, documented treatment and stability for at least 30 days by scans and off steroids at the time of enrollment
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Women of child bearing age and actively menstruating must have a negative pregnancy test prior to study enrollment.
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Ability to understand and the willingness to give informed consent
Exclusion Criteria:
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Untreated hypertension defined as systolic blood pressure > 140 and/or diastolic blood pressure > 90 on two or more occasions within the past 30 days previous to enrollment
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Imaging suggestive of Lymphangitic carcinomatosis in the lung, or use of home oxygen
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Untreated brain metastases.
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Pregnancy or lactation at time of trial enrollment
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Concomitant metastatic disease of another tumor type
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Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
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History of stroke, pulmonary embolus (PE), or myocardial infarction (MI) at any time
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Known Proteinuria of ≥ 2 g/24 h
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HIV-positive participants.
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History of Hepatitis C and Hepatitis B infection
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Documented history of congestive heart failure, and/or LVEF less than 50%
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Concurrent use of medications on the prohibited medications list, unless these medications can be replaced by alternatives. These medications need to be discontinued at least 2 weeks prior to enrollment.
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Presence of other medical condition that, in the sole judgment of the principal investigator, makes the patient not a good candidate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Maryam Nemati Shafaee
- Mirati Therapeutics Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-43432