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

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT01945762

Collaborator

Worldwide Clinical Trials (Other)

Enrollment

Locations

Actual Duration (Months)

3.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

31 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

Actual Study Start Date :

Feb 17, 2014

Actual Primary Completion Date :

Jun 18, 2020

Actual Study Completion Date :

Jun 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
1. patient cohorts (40 patients/cohort) RET positive patient cohorts	Drug: Vandetanib 300 mg Vandetanib commercial tablets Other Names: ZD6474, CAPRELSA
2. patient cohorts (40 patients/cohort) RET negative patient cohorts	Drug: Vandetanib 300 mg Vandetanib commercial tablets Other Names: ZD6474, CAPRELSA

Arm

Intervention/Treatment

1. patient cohorts (40 patients/cohort)

RET positive patient cohorts

Drug: Vandetanib 300 mg

Vandetanib commercial tablets

Other Names:

ZD6474, CAPRELSA

2. patient cohorts (40 patients/cohort)

RET negative patient cohorts

Drug: Vandetanib 300 mg

Vandetanib commercial tablets

Other Names:

ZD6474, CAPRELSA

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Current or planned inclusion/participation in a clinical trial
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

Contacts and Locations

Locations

	Site	City	Country
1	investigational Site Belgium	Belgium	Belgium
2	investigational Site France	France	France
3	investigational Site Germany	Germany	Germany
4	investigational Site Italy	Italy	Italy
5	investigational Site Luxembourg	Luxembourg	Luxembourg
6	investigational Site Netherlands	Netherlands	Netherlands
7	investigational Site Spain	Spain	Spain
8	investigational Site United Kingdom	United Kingdom	United Kingdom