Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

Conditions

• Castration Resistant Prostate Cancer
• Pain
• Prostate Cancer
• Prostatic Neoplasms

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cabozantinib — DRUG
  Tablets taken orally once daily.
• mitoxantrone — DRUG
  Given by IV once every 3 weeks.
• prednisone — DRUG
  Taken twice a day orally by mouth. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.

Study Details

Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan with these agents) or the pain associated with these metastases. This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.

Key Dates

Start date

Mar 31, 2012

Status verified

Apr 2018

Primary completion

Oct 31, 2014

Completion

Jan 13, 2015

Study Design

Enrollment

119 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cabozantinib
  Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules. There will be a maximum of 10 infusions for mitoxantrone placebo.
• Active Comparator: Mitoxantrone/prednisone
  Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets. There will be a maximum of 10 infusions for mitoxantrone.

Primary Outcome Measure

Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported [ Time Frame: Pain response was measured at Week 6 and Week 12 by self-reports of subjects ]

Locations (49)

Find similar trials in Scottsdale, AZ

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