Conditions: Thyroid Cancer
Keywords: Medullary Thyroid Cancer MTC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 330
Healthy volunteers: no

Brief summary:
The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.

The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: XL184 intervention 2: Placebo
Intervention descriptions: intervention 1: Gelatin capsules supplied in 25-mg and 100-mg strengths administered orally daily intervention 2: Gelatin capsules color and size-matched to XL184 capsules administered orally daily

Protocol document: