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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

Inclusion Criteria:

• Histologically confirmed prostate adenocarcinoma

• Bone metastases confirmed by bone scan

• Current androgen deprivation therapy

• Castration-resistant disease based on progression in bone and/or PSA progression

• Recovered from toxicities related to prior treatment, except alopecia, lymphopenia, other non-clinically significant adverse events

• Life expectancy of greater than 3 months

• Normal organ and marrow function

• Capable of understanding and complying with the protocol requirements

• Agree to use medically accepted methods of contraception

• Able to swallow capsules

Exclusion Criteria:

• More than two prior chemotherapy regimens for metastatic prostate cancer

• Known untreated, symptomatic or uncontrolled brain metastases

• Serious or unhealed wound

• Treatment with anticoagulants

• Previously identified allergy or hypersensitivity to components of the study treatment formulation

• History of a different malignancy unless disease-free for at least 5 years, or basal or squamous cell carcinoma of the skin

• Current antiretroviral therapy

• Uncontrolled hypertension

• Uncontrolled intercurrent illness