Breast CancerPhase 1NCT05904730
Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations
A Phase 1 study testing Axitinib in people with Breast Cancer and Ovarian Cancer, run by Lynkcell Europe at 2 sites in Ukraine.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Breast Neoplasms
- What is being tested?
- Axitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUkraine
- Study dates
- 11 Jul 2023to 26 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Ovarian Cancer, Breast Neoplasms, Ovarian Neoplasms, BRCA Mutation, HER2-positive Breast Cancer
- Being tested
- Axitinib
- Keywords
- Axitinib, Inlyta, AG-013736
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxitinibDrug
Also called AG-013736, INLYTA
The starting dose of axitinib is 5 mg twice daily by mouth with meals. (reception is desirable at the same time every day)
| Study group | Role | What they receive |
|---|---|---|
| Axitinib is 5 mg BID administered orally | Experimental | The starting dose of Axitinib 5 mg BID administered orally with food. Receives: Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start11 Jul 2023
- Primary completion9 Nov 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The starting dose of Axitinib is 5 mg BID administered orally with food.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynkcell Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904730
- Sponsor's protocol ID
- A6334536
- Status last verified
- Dec 2024
- First submitted
- 6 Jun 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05904730
- Acronym / sponsor ID
- A6334536
- Conditions
- Breast Cancer, Ovarian Cancer, Breast Neoplasms, Ovarian Neoplasms, BRCA Mutation, HER2-positive Breast Cancer
- Keywords
- Axitinib, Inlyta, AG-013736
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lynkcell EuropeUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The starting dose of Axitinib is 5 mg BID administered orally with food.
| Arm | Type | Receives |
|---|---|---|
| Axitinib is 5 mg BID administered orally | Experimental | Drug: AxitinibThe starting dose of Axitinib 5 mg BID administered orally with food. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AxitinibAlso: AG-013736, INLYTAThe starting dose of axitinib is 5 mg twice daily by mouth with meals. (reception is desirable at the same time every day) | Drug | Axitinib is 5 mg BID administered orally |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Axitinib in people with Breast Cancer and Ovarian Cancer, run by Lynkcell Europe at 2 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.