Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01298323 | Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment | PHASE3 | COMPLETED | 205 | — | — | Feb 25, 2011 | Mar 13, 2025 | Apr 17, 2026 | 66 | Australia, Austria +18 |
The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.
| Arm | Type | Description |
|---|---|---|
| Vandetanib Control | ACTIVE_COMPARATOR | Control - treatment 300mg vandetanib opel label |
| Experimental | EXPERIMENTAL | Experimental - treatment 300mg vandetanib opel label |
| Name | Type | Description |
|---|---|---|
| Patient outreach | BEHAVIORAL | Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner |
| Vandetanib | DRUG | Treatment 300mg vandetanib opel label. |
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Female or male aged 18 years and over * Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient's me...