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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05904730
Other study ID # A6334536
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
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
Health authority
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)

Study Design


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
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