XL184 versus Placebo in Subjects with Thyroid Cancer

• Research type

  Research Study

• Full title

  An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 versus Placebo in Subjects with Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

• IRAS ID

  4678

• Sponsor organisation

  Exelixis Inc

• Eudract number

  2008-002320-29

• ISRCTN Number

  N/A

• Research summary

  Thyroid cancer is the most common endocrine malignancy. Currently there are no available therapies that cure metastatic medullary Thyroid cancer (MTC) and no large-scale or Phase 3 studies have been conducted. Although approved and used for the treatment of thyroid cancer, the drug doxorubicin has limited success and its effects is typically short-lived and toxicity may be significant. Combination chemotherapy regimens have led to increased toxicity and not resulted in greater efficacy. Results of trials performed to date indicate that the overall usefulness of either single-agent or combination chemotherapy is currently limited, with no evidence for clinical benefit as demonstrated by a lack of improvement in progression-free survival (PFS) or OS. There is therefore a clear need for novel therapeutics for patients with metastatic MTC.XL184 is a new chemical entity which is being developed by Exelixis, Inc. (the sponsor for this study) for the treatment of medullary thyroid cancer. XL184 is an investigational drug that has not been approved by any regulatory authorities.This is an International, Randomized, Double-Blinded, Phase 3 Efficacy Study of the investigational drug, XL184 versus Placebo in Participants with Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer The main purpose of this clinical research study is to see if the investigational drug XL184 is effective in delaying the growth of tumors associated with medullary thyroid cancer. In this research study participants will receive either XL184 or placebo (a dummy drug). About 315 people at up to 110 centers worldwide will take part in this study. Participant will be randomized in a 2:1 ratio to receive either XL184 or placebo, respectively for approximately 18 monthsDuring the study participants will be asked to complete a number of pre defined tests and procedures, including physical examinations, electrocardiograms (ECGs) to record the activity of the heart, magnetic resonance imaging (MRI) and/or computerized tomography (CT) scans to assess the size of their tumor(s), and blood and urine collections. All of these tests and procedures could help improve understanding of how this drug may be affecting MTC.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  08/H0904/99

• Date of REC Opinion

  8 Jan 2009

• REC opinion

  Further Information Favourable Opinion