Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT01347788
Phase
PHASE1
Status
Completed

Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. This is similar to how several other cancer drugs work but in addition Cabozantinib also blocks other pathways that may be responsible for allowing cancer cells to become resistant to these other "anti-angiogenic" treatments. So far cabozantinib has been investigated in treating brain cancer and a rare form of thyroid cancer. This study will explore lower doses of cabozantinib with the goal to find the most effective, safe, and tolerable dose without undesirable side effects.

Key Dates

Start date
Apr 30, 2011
Status verified
Oct 2016
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Dose level 0: cabozantinib 40 mg daily
  • Experimental: Cohort 2
    Dose level -1: cabozantinib 20 mg daily
  • Experimental: Expansion cohort
    Dose level 0: cabozantinib 40 mg daily

Primary Outcome Measure

Partial Response in Bone Scan From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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