CompletedNCT01945762Caprelsa104Updated Dec 18, 2024

Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer

An observational study in Symptomatic, Aggressive, Sporadic, Unresectable, Locally and Advanced/Metastatic Medullary Thyroid Cancer (MTC), sponsored by Genzyme, a Sanofi Company. Completed at 8 sites in 8 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Genzyme, a Sanofi Company · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 31
Ages: 18 Years to 99 Years
Sex: All

Study summary

This is a European multinational, multicenter, non-interventional (observational) and prospective study. It is carried on to confirm in real life conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.

Read the detailed description

This is a multinational, multicenter, non-interventional (observational) and prospective study. European countries where vandetanib is on the market will participate in the study.

This study is being conducted to fulfil the specific obligation post-authorisation measure for the conditional marketing authorisation. It is carried on to confirm in real life conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC. The clinical benefit of vandetanib (CAPRELSA™) 300 mg has previously been established in a clinical trial (Study 58) on the basis of a clinically and statistically significant advantage in progression free survival (PFS) which was supported by a high response rate and substantial duration of response.

Conditions studied

Symptomatic, Aggressive, Sporadic, Unresectable, Locally
Advanced/Metastatic Medullary Thyroid Cancer (MTC)

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Keywords

RET Mutation
DIagnostics
Medullary Thyroid Cancer
MTC

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients with Symptomatic, Aggressive, Sporadic, Unresectable, Locally Advanced/Metastatic Medullary Thyroid Cancer (MTC)

Inclusion criteria

Signed informed consent 2. Male or female aged 18 years or above 3. Histological diagnosis of MTC 4. Patients with symptomatic and aggressive sporadic MTC, who have unresectable, locally advanced/metastatic disease. (The factors considered by the investigator to determine a patient's disease to be symptomatic and aggressive will be recorded in the CRF). 5. Measurable disease:

assessment confirmed within the 12 weeks previous to start of treatment, and
defined according to RECIST 1.1: at least one lesion, not irradiated, that can be accurately measured as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and which is suitable for accurate repeated measurements. Measurable lesions with calcifications should not be assessed as target lesions unless no other measurable lesion is available. 6. Known definite RET mutation status (definition according to section 3.2). The status should be:
for patients prescribed with vandetanib: positive or negative
for patients not prescribed with vandetanib: negative RET mutation status must be determined from a tumour sample obtained within 18 months prior to enrollment. It is strongly recommended that a tissue sample obtained within 6 months prior to enrolment is used. 7. For patients newly prescribed vandetanib 300 mg, the prescription should be issued according to marketing authorisation and following the vandetanib Summary of Product Characteristics (SmPC) (Appendix B). The starting dose could be reduced to 200 mg in patients with moderate renal impairment

Exclusion criteria

Exclusion criteria
1. Current or planned inclusion/participation in a clinical trial
2. Patients already receiving vandetanib or who have received vandetanib for their MTC before the study first visit
3. Contraindications according to the vandetanib SmPC (not applicable for patients who do not receive vandetanib): (a) Patients with a QT interval corrected for heart rate (QTc) interval over 480 msec: (i) Congenital long QT syndrome (ii) Concomitant use of vandetanib with the following medicinal products known to also prolong the QT interval and / or induce Torsades de pointes: Arsenic, cisapride, erythromycin intravenous (IV), toremifene, mizolastine, moxifloxacin, Class I A and III antiarrhythmics (b) Currently pregnant or breast feeding (c) Hypersensitivity to the active substance or to any of the excipients (d) Severe renal impairment: creatinine clearance \< 30 ml/minute calculated by Cockcroft-Gault formula. (See Appendix D). (e) Serum bilirubin greater than 1.5 x the upper limit of reference range (ULRR) (f) Potassium, magnesium or calcium outside the normal laboratory range

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 31 participants (actual)
Patient registry: No

Groups and cohorts

1. patient cohorts (40 patients/cohort)
RET positive patient cohorts
Drug: Vandetanib 300 mg
2. patient cohorts (40 patients/cohort)
RET negative patient cohorts
Drug: Vandetanib 300 mg

Interventions

DrugVandetanib 300 mg
Vandetanib commercial tablets
Also known as: ZD6474, CAPRELSA

What researchers measure

Primary outcomes

Assessment of Objective Response Rate
Assessment of Objective Response Rate \[using Response Evaluation Criteria In Solid Tumours (RECIST) 1.1\]
Time frame: From enrollment until study completion, assessed up to 38 months
Assessment of Disease control rate
Assessment of Disease control rate \[using Response Evaluation Criteria In Solid Tumours (RECIST) 1.1\]
Time frame: From enrollment until study completion, assessed up to 38 months
Assessment of Duration of Response
Assessment of Duration of Response (using RECIST 1.1)
Time frame: From enrollment until study completion, assessed up to 38 months
Assessment of Progression Free Survival
Assessment of Progression Free Survival (using RECIST 1.1)
Time frame: From enrollment until study completion, assessed up to 38 months
Evaluation of Safety by assessment of QTc prolongations
Assessment of QTc prolongations
Time frame: From enrollment until study completion, assessed up to 38 months
Evaluation of Safety by assessment of Adverse Events
Assessment of Adverse Events
Time frame: From enrollment until study completion, assessed up to 38 months
Evaluation of Safety by assessment of vital signs
Assessment of Vital signs
Time frame: From enrollment until study completion, assessed up to 38 months
Evaluation of Safety by assessment of laboratory data
Assessment of Laboratory data
Time frame: From enrollment until study completion, assessed up to 38 months

Secondary outcomes

Patient Characteristics
Patient demographics and medical history / Disease characteristics / Death / Treatment information
Time frame: From enrollment until study completion, assessed up to 38 months

Study locations

8 sites

investigational Site Belgium
Belgium, Belgium
investigational Site France
France, France
investigational Site Germany
Germany, Germany
investigational Site Italy
Italy, Italy
investigational Site Luxembourg
Luxembourg, Luxembourg
investigational Site Netherlands
Netherlands, Netherlands
investigational Site Spain
Spain, Spain
investigational Site United Kingdom
United Kingdom, United Kingdom

References and documents

Registry details

Key details

Study ID: NCT01945762
Lead sponsor: Genzyme, a Sanofi Company
Collaborators: Worldwide Clinical Trials
Responsible party: Sponsor
First posted: Sep 19, 2013
Start date: Feb 17, 2014
Primary completion: Jun 18, 2020
Completion: Jun 18, 2020
Last update: Dec 18, 2024

Study contacts

Clinical Sciences & Operations

study director · Sanofi

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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