Studie naar de optimale therapieduur van orale angiogenese remmers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002672-95-NL

Enrollment

Registered

2008-06-04

Start date

2008-07-29

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Patients with a metastatic malignancy, treated with a registered oral angiogenetic inhibitor (tyrosine kinase inhibitor), who have progressive disease according to RECIST on CT-evaluation

Interventions

Trade Name: Nexavar Product Name: Sorafenib Pharmaceutical Form: Coated tablet Trade Name: Sutininib Product Name: Sutininib Pharmaceutical Form: Capsule*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -metastastic or advanced solid cancer that is treated with an oral angiogenesis inhibitor, with clinical indication to stop this therapy based on progressive disease as defined by the RECIST criteria on the CT scan. It needs a minimum of 1 previous evaluation of stable disease and the patient must have been treated with angiogenesis inhibitors for at least 12 weeks. -age =18 years -given informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -pregnant or lactating -metastatic sites solely in bone or liver -contra-indication for CT or Avastinscan (claustrofobia, severe renal function disorder, allergy for contrastfluids, allergy for Avastin) -insufficient condition to continue treatment with angiogenesis inhibitors. -contra-indication for dynamic contrast MRI (deteriorated renal functions with clearance <60ml/min, metal in body, claustrofobia, pacemaker, defibrilator)

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To determine if and how often an unexpected fast increase of disease and complaints shows after stopping the anti-angiogenetic therapy ;Secondary Objective: 2. To predict which patients are at risk for this phenomenom. 3. Record the influence of stopping angiogenesis inhibotors on the quality of life;Primary end point(s): To determine if and how often an unexpected fast increase of disease and complaints shows after stopping the anti-angiogenetic therapy To predict which patients are at risk for this phenomenom. Record the influence of stopping angiogenesis inhibotors on the quality of life	—

Measure

Time frame

Main Objective: 1. To determine if and how often an unexpected fast increase of disease and complaints shows after stopping the anti-angiogenetic therapy ;Secondary Objective: 2. To predict which patients are at risk for this phenomenom. 3. Record the influence of stopping angiogenesis inhibotors on the quality of life;Primary end point(s): To determine if and how often an unexpected fast increase of disease and complaints shows after stopping the anti-angiogenetic therapy To predict which patients are at risk for this phenomenom. Record the influence of stopping angiogenesis inhibotors on the quality of life

—

Countries

Netherlands

Outcome results

None listed

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