Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations

Study Overview
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Brief Summary
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This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach. The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.

Detailed Description
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This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach. The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols. The addition of Axitinib to existing treatment protocols and to fractionated irradiation without functional normalization of the tumor vasculature can significantly improve response to therapy, contributing to the breakdown of the metabolic symbiosis of adaptive drug resistance.

Official Title
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Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations Independent of HER2 Expression With Progression After Previous Treatment

Conditions
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Breast Cancer, Ovarian Cancer, Breast Neoplasms, Ovarian Neoplasms, BRCA Mutation, HER2-positive Breast Cancer, HER2-negative Breast Cancer, HER-2 Protein Overexpression

Intervention / Treatment
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* Drug: Axitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically and immunohistochemically confirmed status of the tumor process мale or female, age ≥ 18 years Karnofsky performance status ≥ 60 signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion Criteria: Grade 3 bleeding NCI CTCAE prior to study enrollment cardiac arrhythmias ≥2 according to NCI CTCAE with a corrected QT interval (QTcF) on the screening ECG >480 ms. pregnancy or breastfeeding. All female subjects of reproductive potential must have a negative pregnancy test (serum) prior to enrollment. Male subjects must be surgically sterile or must consent to the use of effective contraception during therapy. severe acute or chronic psychiatric condition or disorder with risk associated with participation in the study congestive heart failure (CHF) class III or higher according to the New York Heart Association (NYHA) subjects with arterial thrombotic events / venous thrombosis in the previous 12 months (axitinib has never been studied in this population)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The starting dose of Axitinib is 5 mg BID administered orally with food.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axitinib is 5 mg BID administered orally<br>The starting dose of Axitinib 5 mg BID administered orally with food. | Drug: Axitinib<br>* The starting dose of axitinib is 5 mg twice daily by mouth with meals. (reception is desirable at the same time every day)<br>* Other names: INLYTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor effect of axitinib (INLYTA) among patients with solid tumors with BRCA 1/2 mutations independent of HER2 expression, with progression after previous treatment, including radiotherapy | Percent reduction of longest diameter of tumor and (or) metastases in millimeters | up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axitinib, Inlyta, AG-013736