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

July 11, 2023 updated by: Lynkcell Europe

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: up to 90 days
Percent reduction of longest diameter of tumor and (or) metastases in millimeters
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lynkcell Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2023

Primary Completion (Estimated)

September 24, 2024

Study Completion (Estimated)

November 9, 2024

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6334536

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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