Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer (VERIFY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01876784
First received: June 11, 2013
Last updated: September 5, 2014
Last verified: September 2014

June 11, 2013
September 5, 2014
September 2013
August 2015   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Once 155 progression events have occurred.
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). ] [ Designated as safety issue: No ]
Once 155 progression events have occurred. RECIST measurements taken every 12 weeks from randomization. Time point(s) at which outcome measure is assessed.
Complete list of historical versions of study NCT01876784 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Once 155 progression events have occurred.
  • 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 ] [ Designated as safety issue: No ]
    Once 155 progression events have occured.
  • 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 ] [ Designated as safety issue: Yes ]
    Once 155 progression events have occurred.
  • 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 ] [ Designated as safety issue: No ]
    Once 155 progression events have occurred.
  • 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. ] [ Designated as safety issue: No ]
    Once 155 progression events have occurred.
  • 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. ] [ Designated as safety issue: No ]
    Once 155 progression events have occurred and when 50% of randomized patients have died due to any cause.
  • 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. ] [ Designated as safety issue: No ]
    Estimated time frame up to 155 progression events have occured or up to individual progression of patient.
  • 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. ] [ Designated as safety issue: No ]
    Estimated time frame up to 155 progression events have occured or up to individual progression of patient.
  • 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. ] [ Designated as safety issue: No ]
    Estimated time frame up to 155 progression events have occured or up to individual progression of patient.
  • 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. ] [ Designated as safety issue: No ]
    Estimated time frame up to 155 progression events have occured or up to individual progression of patient.
  • 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 at 20 months after initial 25.5 months. ] [ Designated as safety issue: No ]
    Once 155 progression events have occurred. Analysis of overall survival to be repeated when 50% of randomised patients have died due to any cause.
  • 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 ] [ Designated as safety issue: No ]
    Estimated time frame up to 155 progression events have occured.
  • 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, assess up to 25.5 months ] [ Designated as safety issue: Yes ]
    Once 155 progression events have occurred.
  • 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 at 20 months after initial 25.5 months. ] [ Designated as safety issue: No ]
    Once 155 progression events have occurred. Analysis of overall survival to be repeated when 50% of randomised patients have died due to any cause.
  • 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. ] [ Designated as safety issue: No ]
    Once 155 progression events have occurred. Analysis of overall survival to be repeated when 50% of randomised patients have died due to any cause.
  • 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. ] [ Designated as safety issue: No ]
    Once 155 progression events have occurred. Analysis of overall survival to be repeated when 50% of randomised patients have died due to any cause.
  • 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. ] [ Designated as safety issue: No ]
    Estimated time frame up to 155 progression events have occured or up to individual progression of patient.
  • 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. ] [ Designated as safety issue: No ]
    Estimated time frame up to 155 progression events have occured or up to individual progression of patient.
  • 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. ] [ Designated as safety issue: No ]
    Estimated time frame up to 155 progression events have occured or up to individual progression of patient.
  • 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. ] [ Designated as safety issue: No ]
    Estimated time frame up to 155 progression events have occured or up to individual progression of patient.
Not Provided
Not Provided
 
Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer
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.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Differentiated Thyroid Cancer
  • Drug: vandetanib
    300 mg (3 x 100 mg tablets) will be dosed orally, once daily
    Other Name: CAPRELSA
  • Drug: placebo
    300 mg (3 x 100 mg tablets) will be dosed orally, once daily
    Other Name: CAPRELSA placebo
  • Experimental: 1 Vandetanib 300 mg
    vandetanib clinical trials tablets
    Intervention: Drug: vandetanib
  • Placebo Comparator: 2 Placebo 300 mg
    Placebo to match vandetanib tablet
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
255
May 2017
August 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Gabriella Mariani, MSD ClinicalTrialTransparency@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service - 877-400-4656 astrazeneca@emergingmed.com
United States,   Brazil,   China,   Czech Republic,   Denmark,   France,   Italy,   Japan,   Poland,   Russian Federation,   Spain,   Sweden
 
NCT01876784
D4203C00011, 2013-000422-58
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Martin Schlumberger, PROFESSOR, M.D. Department of Nuclear Medicine and Endocrine Oncology, Institut Gustave Roussy, 94805 Villejuif, France
Study Director: Gabriella Mariani, M.D., PHD Da Vinci Building Melbourn Science Park, Alderley Park, Macclesfield, Cheshire, England
AstraZeneca
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP