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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 Papillary or Poorly Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy.


Phase 3
18 Years
N/A
Not Enrolling
Both
Papillary Differentiated Thyroid Cancer, Poorly Differentiated Thyroid Cancer

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Trial Information

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 Papillary or Poorly 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 Papillary or Poorly
Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are
Refractory or Unsuitable for Radioiodine (RAI) Therapy.


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 poorly differentiated or papillary
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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determination of the efficacy (as assessed by progression-free survival) of vandetanib when compared to placebo in the patient population

Outcome Description:

Once 155 progression events have occurred. RECIST measurements taken every 12 weeks from randomization. Time point(s) at which outcome measure is assessed.

Outcome Time Frame:

Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow-up).

Safety Issue:

No

Principal Investigator

Martin Schlumberger, PROFESSOR, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Nuclear Medicine and Endocrine Oncology, Institut Gustave Roussy, 94805 Villejuif, France

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

D4203C00011

NCT ID:

NCT01876784

Start Date:

July 2013

Completion Date:

May 2017

Related Keywords:

  • Papillary Differentiated Thyroid Cancer, Poorly Differentiated Thyroid Cancer
  • vandetanib, ZD 6474, Differentiated Thyroid Cancer
  • Thyroid Neoplasms
  • Thyroid Diseases

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