Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metasta... | Recruiting
Observational Study to Evaluate Van... | Recruiting
Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer
Caprelsa104

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Medical Conditions
  • Symptomatic, Aggressive, Sporadic, Unresectable, Locally
  • Advanced/Metastatic Medullary Thyroid Cancer (MTC)
Primary Contact Details
For site information, send an email with site number to
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01945762
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • 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.
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Observational
Intervention
Drug : Vandetanib 300 mg

Study Arm Groups : 1. patient cohorts (40 patients/cohort), 2. patient cohorts (40 patients/cohort)

Intervention Type
See Interventions above
Primary Outcome Measures
    Assessment of Objective Response Rate; From enrollment until study completion, assessed up to 38 months; Assessment of Disease control rate; From enrollment until study completion, assessed up to 38 months; Assessment of Duration of Response; From enrollment until study completion, assessed up to 38 months; Assessment of Progression Free Survival; From enrollment until study completion, assessed up to 38 months; Evaluation of Safety by assessment of QTc prolongations; From enrollment until study completion, assessed up to 38 months; Evaluation of Safety by assessment of Adverse Events; From enrollment until study completion, assessed up to 38 months; Evaluation of Safety by assessment of vital signs; From enrollment until study completion, assessed up to 38 months; Evaluation of Safety by assessment of laboratory data; From enrollment until study completion, assessed up to 38 months
Secondary Outcome Measures
    Patient Characteristics; From enrollment until study completion, assessed up to 38 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - 99 Years
Who Can Participate
Patients
Number of Participants
80
Participant Inclusion Criteria
    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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Glasgow
Central
Local Institution
London
Greater London
Manchester
Sheffield
Sutton
Trial Contact(s)
Primary Trial Contact
For site information, send an email with site number to
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Belgium, France, Germany, Italy, Luxembourg, Netherlands, Spain, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
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
EudraCT Number
Not available for this trial
Funder(s)
  • Worldwide Clinical Trials
Other Study ID Numbers
D4200C00104
Sponsor(s)
Genzyme, a Sanofi Company
Key Dates

Recruitment Start Date

Feb 2014

Recruitment End Date

Sep 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

10 Sep 2013

Date updated in source

28 Feb 2017