Status:
UNKNOWN
Validation of Tie2 as the First Tumour Vascular Response Biomarker for VEGF Inhibitors: VALTIVE1
Lead Sponsor:
University of Manchester
Collaborating Sponsors:
Cancer Research UK
Centre for Trials Research, Cardiff University
Conditions:
Ovary Cancer
Eligibility:
FEMALE
16+ years
Brief Summary
Tumours require a blood supply to provide them with oxygen and nutrients and to enable spread of cancer through blood vessels to other organs (metastasis). The formation of new blood vessels is known ...
Detailed Description
VALTIVE1 is a multi-centre, single arm, non-interventional biomarker study, which will enrol 176 participants who are 16 years or older and who have FIGO stage IIIc/ IV ovarian cancer on treatment wit...
Eligibility Criteria
Inclusion
- In order to be eligible for participation in this trial, the patient must:
- Be willing and able to provide written informed consent for the trial
- Age 16 years or over on day of signing informed consent
- 3\. Histologically proven ovarian, primary peritoneal or fallopian tube cancer (henceforth referred to collectively as Ovarian Cancer - OC) FIGO stage III with residual disease of more than 1cm; or stage IV; or stage III at presentation treated with neoadjuvant chemotherapy; or stage III with contraindication to debulking surgery chemotherapy
- Planned to receive treatment with bevacizumab or biosimilar bevacizumab
- Be scheduled to receive at least 2 successive doses of bevacizumab with 6 or more weeks of follow up blood samples after the first dose of bevacizumab if given pre-operatively; or to start bevacizumab post-operatively
- Be eligible for receiving treatment with first line, 3-weekly carboplatin and paclitaxel chemotherapy
- Be willing to provide blood samples and comply with trial-specific procedures
Exclusion
- The patient must be excluded from participating in the trial if the patient:
- Is unsuitable for treatment with VEGF inhibitors
- Is unable or unwilling to comply with study procedures
- Is participating in a clinical study with an investigational product other than carboplatin, paclitaxel and bevacizumab
- Is judged by the investigator to be unlikely to comply with study procedures
- Is pregnant or could become pregnant and is not using adequate contraception
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g. HCV RNA is detected). Testing only required if patient has a history of either of these
Key Trial Info
Start Date :
January 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04523116
Start Date
January 14 2021
End Date
June 1 2023
Last Update
October 5 2021
Active Locations (4)
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1
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
2
The Christie NHS Foundation Trust
Manchester, United Kingdom
3
East and North Hertfordshire NHS Trust
Northwood, United Kingdom
4
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom