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Trial record 1 of 1 for:    NCT01945762
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Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer (Caprelsa104)

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ClinicalTrials.gov Identifier: NCT01945762
Recruitment Status : Recruiting
First Posted : September 19, 2013
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief 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.

Condition or disease Intervention/treatment
Symptomatic, Aggressive, Sporadic, Unresectable, Locally Advanced/Metastatic Medullary Thyroid Cancer (MTC) Drug: Vandetanib 300 mg

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
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : February 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


Group/Cohort Intervention/treatment
1. patient cohorts (40 patients/cohort)
RET positive patient cohorts
Drug: Vandetanib 300 mg
Vandetanib commercial tablets
Other Name: ZD6474, CAPRELSA

2. patient cohorts (40 patients/cohort)
RET negative patient cohorts
Drug: Vandetanib 300 mg
Vandetanib commercial tablets
Other Name: ZD6474, CAPRELSA




Primary Outcome Measures :
  1. 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]

  2. 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]

  3. 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)

  4. 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)

  5. Evaluation of Safety by assessment of QTc prolongations [ Time Frame: From enrollment until study completion, assessed up to 38 months ]
    Assessment of QTc prolongations

  6. Evaluation of Safety by assessment of Adverse Events [ Time Frame: From enrollment until study completion, assessed up to 38 months ]
    Assessment of Adverse Events

  7. Evaluation of Safety by assessment of vital signs [ Time Frame: From enrollment until study completion, assessed up to 38 months ]
    Assessment of Vital signs

  8. Evaluation of Safety by assessment of laboratory data [ Time Frame: From enrollment until study completion, assessed up to 38 months ]
    Assessment of Laboratory data


Secondary Outcome Measures :
  1. Patient Characteristics [ Time Frame: From enrollment until study completion, assessed up to 38 months ]
    Patient demographics and medical history / Disease characteristics / Death / Treatment information



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945762


Contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

Locations
Belgium
Research Site Active, not recruiting
Brussels, Belgium
France
Research Site Active, not recruiting
Bordeaux, France
Research Site Terminated
Lyon, France
Research Site Recruiting
Paris, France
Research Site Recruiting
Villejuif, France
Germany
Research Site Recruiting
Augsburg, Germany
Research Site Active, not recruiting
Essen, Germany
Research Site Active, not recruiting
Heidelberg, Germany
Research Site Active, not recruiting
Munchen, Germany
Italy
Research Site Recruiting
Catania, Italy
Research Site Recruiting
MIlano, Italy
Research Site Active, not recruiting
Milano, Italy
Research Site Active, not recruiting
Naples, Italy
Research Site Recruiting
Padova, Italy
Research Site Recruiting
Pisa, Italy
Research Site Recruiting
Siena, Italy
Luxembourg
Research Site Active, not recruiting
Luxembourg, Luxembourg
Netherlands
Research Site Active, not recruiting
Groningen, Netherlands
Research Site Recruiting
Leiden, Netherlands
Spain
Research Site Recruiting
Barcelona, Spain
Research Site Active, not recruiting
Madrid, Spain
Research Site Recruiting
Madrid, Spain
Research Site Active, not recruiting
Oviedo, Spain
Research Site Terminated
Sevilla, Spain
United Kingdom
Research Site Terminated
Glasgow, United Kingdom
Research Site Recruiting
London, United Kingdom
Research Site Terminated
London, United Kingdom
Research Site Active, not recruiting
Manchester, United Kingdom
Research Site Active, not recruiting
Sheffield, United Kingdom
Research Site Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Worldwide Clinical Trials
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01945762     History of Changes
Other Study ID Numbers: D4200C00104
OBS14778 ( Other Identifier: Sanofi )
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
RET Mutation
DIagnostics
Medullary Thyroid Cancer
MTC

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Aggression
Carcinoma, Neuroendocrine
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Behavioral Symptoms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue