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

Lynkcell Europe

Status and phase: Completed; Phase 1

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

Treatments: Drug: Axitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05904730

A6334536

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Axitinib is 5 mg BID administered orally

Experimental group

Description:

The starting dose of Axitinib 5 mg BID administered orally with food.

Treatment:

Drug: Axitinib