Clinical trial · Interventional
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
A Randomized,Int.,Open-Label Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients With Locally Advanced or Metastatic MTC Experience Grade 2 or Higher AEs in the First 12 Months of Treatment With Vandetanib
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Medullary Thyroid Cancer | — | UNRESOLVED | — |
| Medullary Thyroid Cancer | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient outreach | Behavioral | — | UNRESOLVED |
| Vandetanib | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vandetanib Control
- description
- Control - treatment 300mg vandetanib opel label
- interventionNames
- Drug: Vandetanib
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Experimental - treatment 300mg vandetanib opel label
- interventionNames
- Behavioral: Patient outreach
- Drug: Vandetanib
Primary outcomes (1)
- measure
- Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 medical chart * WHO or ECOG Performance status 0-2 * Negative pregnancy test (urine or serum) for female patients of childbearing potential Exclusion Criteria: * Unstable brain metastases or spinal cord compression that require treatment, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days * Major surgery within 4 weeks before randomization * The last dose of prior chemotherapy received less than 3 weeks prior to randomization * Radiation therapy not completed prior to the first dose of vandetanib * Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhythmia * Creatinine clearance \<30 ml/min (calculated by Cockcroft-Gault formula),Patients with moderate renal impairment, defined as creatinine clearance ≥30 to \<50 ml/min, must start vandetanib at a reduced dose of 200 mg
References
Publications (0)
Data not yet available