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A multicentre observational study for the long term follow up of subjects that have been treated with enadenotucirev during interventional clinical trial

A multicentre observational study for the long term follow up of subjects that have been treated with enadenotucirev during interventional clinical trial - Long term follow up of subjects treated with enadenotucirev

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-004777-40-ES
Enrollment
11
Registered
2017-01-25
Start date
2017-06-12
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Product Name: Enadenotucirev Product Code: ColoAd1 Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Enadenotucirev CAS Number: NA Current Sponsor code: ColoAd1 Other de

Sponsors

PsiOxus Therapeutics Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: l. Have participated in a clinical trial during which they received enadenotucirev, irrespective of the route of administration, dose received or tumour type being treated. 2. Able and willing to provide signed and dated written informed consent. 3. Able to comply with study procedures in the Investigator's opinión. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Main Objective: To follow up subjects that have received enadenotucirev during a clinical trial to assess their long term well-being;Secondary Objective: To collect all cancer treatments received after discontinuing treatment with enadenotucirev.;Primary end point(s): Time to death;Timepoint(s) of evaluation of this end point: Visits or telephone contacts will take place at intervals no greater than every 3 months to assess subject well-being and record cancer treatments received.

Secondary

MeasureTime frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable

Countries

Belgium, Spain, United Kingdom, United States

Contacts

Public ContactClinical Trials Contact

PsiOxus Therapeutics Ltd

Enquiries@psioxus.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026