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

• Status: Not yet recruiting
• Trial end date: 2024-11-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lynkcell Europe
• Treatments: Axitinib

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)