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

This study is currently recruiting participants.
Verified April 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01876784
First received: June 11, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Differentiated Thyroid Cancer
Drug: vandetanib
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 255
Study Start Date: September 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Vandetanib 300 mg
vandetanib clinical trials tablets
Drug: vandetanib
300 mg (3 x 100 mg tablets) will be dosed orally, once daily
Other Name: CAPRELSA
Placebo Comparator: 2 Placebo 300 mg
Placebo to match vandetanib tablet
Drug: placebo
300 mg (3 x 100 mg tablets) will be dosed orally, once daily
Other Name: CAPRELSA placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01876784

Contacts
Contact: Ian Smith, MSD ClinicalTrialTransparency@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service - 877-400-4656 astrazeneca@emergingmed.com

  Show 59 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Martin Schlumberger, PROFESSOR, M.D. Department of Nuclear Medicine and Endocrine Oncology, Institut Gustave Roussy, 94805 Villejuif, France
Study Director: Ian Smith, M.D., PHD 11G34, Mereside, Alderley Park, Macclesfield, Cheshire, England
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01876784     History of Changes
Other Study ID Numbers: D4203C00011, 2013-000422-58
Study First Received: June 11, 2013
Last Updated: April 2, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
China: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Czech Republic: State Institute for Drug Control
Brazil: National Health Surveillance Agency
United States: Food and Drug Administration
Denmark: Ethics Committee

Keywords provided by AstraZeneca:
vandetanib, AZD 6474, Differentiated Thyroid Cancer

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014