Phase 1 N=34 Treatment

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

Prostate Adenocarcinoma

Bottom Line

View on ClinicalTrials.gov: NCT01347788 ↗

Enrolled (actual)

Serious AEs

5.9%

Results posted

Nov 2015

Primary outcome: Primary: Partial Response in Bone Scan From Baseline to Week 6 — 9; 1; 6 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: cabozantinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Massachusetts General Hospital
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Partial Response in Bone Scan From Baseline to Week 6	9; 1; 6	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01347788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.