Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations
NCT ID: NCT05904730
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2023-07-11
2024-12-26
Brief Summary
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The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Axitinib is 5 mg BID administered orally
The starting dose of Axitinib 5 mg BID administered orally with food.
Axitinib
The starting dose of axitinib is 5 mg twice daily by mouth with meals. (reception is desirable at the same time every day)
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Lynkcell Europe
OTHER
Responsible Party
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Locations
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Trials TEAM
Dnipro, , Ukraine
Trials TEAM
Kyiv, , Ukraine
Countries
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Related Links
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Other Identifiers
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A6334536
Identifier Type: -
Identifier Source: org_study_id