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

NCT01945762 | Completed

• 2 other identifiers: D4200C00104OBS14778
• Study Type: observational
• Target: 31
• Locations: 8 countries
• Sites: 8

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.

Conditions

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

Keywords

RET Mutation; DIagnostics; Medullary Thyroid Cancer; MTC

Outcome Measures

Primary Outcomes (8)

• Assessment of Objective Response Rate

  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

  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

  Assessment of Duration of Response (using RECIST 1.1)

  From enrollment until study completion, assessed up to 38 months

• Assessment of Progression Free Survival

  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

  Assessment of QTc prolongations

  From enrollment until study completion, assessed up to 38 months

• Evaluation of Safety by assessment of Adverse Events

  Assessment of Adverse Events

  From enrollment until study completion, assessed up to 38 months

• Evaluation of Safety by assessment of vital signs

  Assessment of Vital signs

  From enrollment until study completion, assessed up to 38 months

• Evaluation of Safety by assessment of laboratory data

  Assessment of Laboratory data

  From enrollment until study completion, assessed up to 38 months

Secondary Outcomes (1)

• Patient Characteristics

  From enrollment until study completion, assessed up to 38 months

Study Arms (2)

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

Vandetanib 300 mg DRUG

Vandetanib commercial tablets

Also known as: ZD6474, CAPRELSA

1. patient cohorts (40 patients/cohort); 2. patient cohorts (40 patients/cohort)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. 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

You may not qualify if:

• Patients already receiving vandetanib or who have received vandetanib for their MTC before the study first visit
• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead
• Worldwide Clinical Trials: collaborator

Study Sites (8)

investigational Site Belgium

Belgium, Belgium

Location

investigational Site France

France, France

Location

investigational Site Germany

Germany, Germany

Location

investigational Site Italy

Italy, Italy

Location

investigational Site Luxembourg

Luxembourg, Luxembourg

Location

investigational Site Netherlands

Netherlands, Netherlands

Location

investigational Site Spain

Spain, Spain

Location

investigational Site United Kingdom

United Kingdom, United Kingdom

Location

Related Links

• OBS14778 clinical study synopsis and addendum

MeSH Terms

Conditions

Aggression; Carcinoma, Medullary

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 19, 2013
• Study Start: February 17, 2014
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

FR (1); ES (1); DE (1); BE (1); LU (1); IT (1); NL (1); GB (1)