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

NCT05904730 | Completed Phase 1

• 1 other identifier: A6334536
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Axitinib; Inlyta; AG-013736

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Axitinib is 5 mg BID administered orally

EXPERIMENTAL

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

Drug: Axitinib

Interventions

Axitinib DRUG

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

Also known as: AG-013736, INLYTA

Axitinib is 5 mg BID administered orally

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lynkcell Europe: lead

Study Sites (2)

Trials TEAM

Dnipro, 49102, Ukraine

Location

Trials TEAM

Kyiv, 04107, Ukraine

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: July 11, 2023
• Primary Completion: November 9, 2024
• Study Completion: December 26, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

UA (2)