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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05904730
• Other study ID #: A6334536
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: July 11, 2023
• Est. completion date: November 9, 2024

Study information

• Verified date: July 2023
• Source: Lynkcell Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: November 9, 2024
• Est. primary completion date: September 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically and immunohistochemically confirmed status of the tumor process
• ?ale 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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Axitinib
The starting dose of axitinib is 5 mg twice daily by mouth with meals. (reception is desirable at the same time every day)

Locations

Country	Name	City	State
Ukraine	Trials TEAM	Dnipro
Ukraine	Trials TEAM	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Lynkcell Europe

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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