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

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Primary Purpose

Status

Enrolling by invitation

Phase

Phase 1

Locations

Ukraine

Study Type

Interventional

Intervention

Axitinib

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Axitinib, Inlyta, AG-013736

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Trials TEAM
Trials TEAM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Axitinib is 5 mg BID administered orally

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05904730

First Posted

June 6, 2023

Last Updated

July 11, 2023

Sponsor

Lynkcell Europe

1. Study Identification

Unique Protocol Identification Number

NCT05904730

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

July 11, 2023 (Actual)

Primary Completion Date

September 24, 2024 (Anticipated)

Study Completion Date

November 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lynkcell Europe

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Axitinib is 5 mg BID administered orally

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Axitinib

Other Intervention Name(s)

AG-013736, INLYTA

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Percent reduction of longest diameter of tumor and (or) metastases in millimeters

Time Frame

up to 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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)

Facility Information:

Facility Name

Trials TEAM

City

Dnipro

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Trials TEAM

City

Kyiv

ZIP/Postal Code

04107

Country

Ukraine

12. IPD Sharing Statement

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/24755544/

Description

Related Info

URL

https://www.pennmedicine.org/news/news-releases/2022/november/why-cancers-caused-by-brca-mutations-recur

Description

Related Info

URL

https://hccpjournal.biomedcentral.com/articles/10.1186/s13053-021-00193-y

Description

Related Info

Breast Cancer, Ovarian Cancer, Breast Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial