Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer (Caprelsa104)

October 15, 2020 updated by: Genzyme, a Sanofi Company

European, Observational, Prospective Study to Evaluate the Benefit/Risk of Vandetanib in RET Mutation Negative and Positive Patients With Symptomatic, Aggressive, Sporadic, Unresectable, Locally Advanced/Metastatic Medullary Thyroid Cancer

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. 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

      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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1. patient cohorts (40 patients/cohort)
RET positive patient cohorts
Vandetanib commercial tablets
Other Names:
  • ZD6474, CAPRELSA
2. patient cohorts (40 patients/cohort)
RET negative patient cohorts
Vandetanib commercial tablets
Other Names:
  • ZD6474, CAPRELSA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2014

Primary Completion (Actual)

June 18, 2020

Study Completion (Actual)

June 18, 2020

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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