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

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

NCT ID: NCT05904730

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

Conditions: Official terms:
Breast Neoplasms
Neoplasms
Ovarian Neoplasms
Axitinib

Conditions: Keywords:
Axitinib
Inlyta
AG-013736

Study type: Interventional

Study phase: Phase 1

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: The starting dose of Axitinib is 5 mg BID administered orally with food.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Axitinib
Description: The starting dose of axitinib is 5 mg twice daily by mouth with meals. (reception is desirable at the same time every day)
Arm group label: Axitinib is 5 mg BID administered orally

Other name: AG-013736

Other name: INLYTA

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.

Criteria for 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Trials TEAM

Address:
City: Dnipro
Zip: 49102
Country: Ukraine

Facility:
Name: Trials TEAM

Address:
City: Kyiv
Zip: 04107
Country: Ukraine

Start date: July 11, 2023

Completion date: November 9, 2024

Lead sponsor:
Agency: Lynkcell Europe
Agency class: Other

Source: Lynkcell Europe

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05904730
https://pubmed.ncbi.nlm.nih.gov/24755544/
https://www.pennmedicine.org/news/news-releases/2022/november/why-cancers-caused-by-brca-mutations-recur
https://hccpjournal.biomedcentral.com/articles/10.1186/s13053-021-00193-y