BRCA Mutation, Breast Cancer, Breast Neoplasms, HER2-negative Breast Cancer, HER2-positive Breast Cancer, HER-2 Protein Overexpression, Ovarian Cancer, Ovarian Neoplasms
Conditions
Keywords
Axitinib, Inlyta, AG-013736
Brief summary
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
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.
Interventions
DRUGAxitinib
The starting dose of axitinib is 5 mg twice daily by mouth with meals. (reception is desirable at the same time every day)
Sponsors
Lynkcell Europe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The starting dose of Axitinib is 5 mg BID administered orally with food.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 90 days | Percent reduction of longest diameter of tumor and (or) metastases in millimeters |
Countries
Ukraine
Outcome results
None listed