NCT05904730CompletedPhase 1
Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations
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
Source: ClinicalTrials.gov · Last updated 30 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 6 Jun 2023
- Start date
- 11 Jul 2023
- Primary completion date
- 9 Nov 2024
- Lead sponsor
- Lynkcell Europe
- Diseases
- Ovarian cancer
- NCT number
- NCT05904730
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 11 Jul 2023 to the primary completion date, 9 Nov 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Grade 3 bleeding NCI CTCAE prior to study enrollment
- subjects with arterial thrombotic events / venous thrombosis in the previous 12 months (axitinib has never been studied in this population)
Other illness
- 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)
Lab values
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Trials TEAM Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Trials TEAM Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.