Clinical trial NCT05904730: Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Ovarian Cancer
Breast Neoplasms
Ovarian Neoplasms
BRCA Mutation
HER2-positive Breast Cancer
HER2-negative Breast Cancer
HER-2 Protein Overexpression
Keywords: Axitinib
Inlyta
AG-013736
Lead sponsor: Lynkcell Europe
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The starting dose of Axitinib is 5 mg BID administered orally with food.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dnipro
country: Ukraine
facility: Trials TEAM
city: Kyiv
country: Ukraine
facility: Trials TEAM
Study officials:
References: