Overview

This trial is active, not recruiting.

Condition differentiated thyroid cancer
Treatments vandetanib, placebo
Phase phase 3
Targets VEGF, EGFR
Sponsor AstraZeneca
Start date September 2013
End date August 2015
Trial size 238 participants
Trial identifier NCT01876784, 2013-000422-58, D4203C00011

Summary

The Study is designed to assess the efficacy, safety and tolerability of vandetanib 300 mg daily in patients with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine (RAI) therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
vandetanib clinical trials tablets
vandetanib CAPRELSA
300 mg (3 x 100 mg tablets) will be dosed orally, once daily
(Placebo Comparator)
Placebo to match vandetanib tablet
placebo CAPRELSA placebo
300 mg (3 x 100 mg tablets) will be dosed orally, once daily

Primary Outcomes

Measure
Determination of the efficacy (as assessed by progression-free survival) of vandetanib when compared to placebo in the patient population
time frame: Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow-up). RECIST measurements taken every 12 weeks from randomization

Secondary Outcomes

Measure
Determination of the efficacy of vandetanib when compared to placebo in the patient population as assessed by efficacy variables including duration of response.
time frame: Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow up). RECIST measurements taken every 12 weeks from randomization
Demonstration of an improvement in time to worsening of pain in patients treated with vandetanib when compared to placebo in the patient population.
time frame: Patient assessments at baseline, week 4, 8, 12 and then 12 weekly thereafter, assess up to 25.5 months
Evaluation of the safety and tolerability of vandetanib treatment in the patient population by assessment of adverse events, vital signs, laboratory parameters and electrocardiography.
time frame: Safety assessments at baseline, Weeks 1, 2, 4, 8, 12 and then 12 weekly thereafter
Determination of the efficacy of vandetanib when compared to placebo in the patient population as assessed by efficacy variables including objective response rate.
time frame: Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow up). RECIST measurements taken every 12 weeks from randomization
Determination of the efficacy of vandetanib when compared to placebo in the patient population as assessed by efficacy variables including change in tumour size
time frame: Assessed tumour size at screening, Weeks 7, 8 and then 12 weekly thereafter and at Discontinuation visit, estimated time frame at 25.5 months.
Determination of the efficacy of vandetanib when compared to placebo in the patient population as assessed by efficacy variables including overall survival
time frame: Estimated time frame at 20 months after initial 25.5 months.
Evaluation of the pharmacokinetics of vandetanib in the patient population by assessment of V/F.
time frame: Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then 12 weekly thereafter until discontinuation.
Evaluation of the pharmacokinetics of vandetanib in the patient population by assessment of Cmax
time frame: Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then 12 weekly thereafter until discontinuation.
Evaluation of the pharmacokinetics of vandetanib in the patient population by assessment of AUCss
time frame: Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then 12 weekly thereafter until discontinuation.
Evaluation of the pharmacokinetics of vandetanib in the patient population by assessment of CL/F
time frame: Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then 12 weekly thereafter until discontinuation.

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

Inclusion Criteria: - Provision of informed consent to participate in the study as well as provision of informed consent to provide a sample of a previously obtained archival tumour biopsy. - Female or male aged 18 years and older with previously confirmed histological diagnosis of locally advanced or metastatic differentiated (excluding minimally invasive follicular) thyroid cancer not amenable to surgical resection, external beam radiotherapy or local therapy. - Measurable disease defined as at least one lesion, not irradiated within 12 weeks of the date of randomisation, that can be accurately measured at baseline. - Patients must have progression and be RAI-refractory/resistant or unsuitable for RAI. - TSH suppression below 0.5 mU/L is required. Exclusion Criteria: - Risk of prolonged QTc as defined by history of QT prolongation; current therapy with any medication known to be associated with Torsades de Pointes or prolongation of QT; congenital long QT syndrome. - Previous therapy with approved or investigational tyrosine kinase or anti-VEGF receptor inhibitors or targeted therapies (e.g. multi-targeted kinase inhibitors such as sorafenib, AMG-706, sunitinib, pazopanib, lenvatinib). - RAI therapy within 12 weeks prior to first dose of study drug, and radiation therapy other than RAI, including external beam, if not completed prior to randomisation. - Inadequate organ function as defined by elevated ALT, AST, ALP or bilirubin; or creatinine clearance <50 ml/min.

Additional Information

Official title A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA) 300 mg in Patients With Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy.
Principal investigator Martin Schlumberger, PROFESSOR, M.D.
Description A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA) 300 mg in Patients with Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.