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

Sponsor

Lynkcell Europe (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05904730

Collaborator

(none)

Enrollment

Locations

Arm

16.6

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Ovarian Cancer Breast Neoplasms Ovarian Neoplasms BRCA Mutation HER2-positive Breast Cancer HER2-negative Breast Cancer HER-2 Protein Overexpression	Drug: Axitinib	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 24, 2023

Anticipated Primary Completion Date :

Sep 24, 2024

Anticipated Study Completion Date :

Nov 9, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Axitinib is 5 mg BID administered orally The starting dose of Axitinib 5 mg BID administered orally with food.	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) Other Names: AG-013736 INLYTA

Arm

Intervention/Treatment

Experimental: Axitinib is 5 mg BID administered orally

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

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)

Other Names:

AG-013736

INLYTA

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)