Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2011 |
| End Date: | May 2013 |
Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases
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.
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.
Cabozantinib will be taken by mouth daily. The first five treatment cycles will be 21 days.
All cycles after that will be 42 days long. Patients will keep a diary to record study drug
dosing.
During the screening phase patients will receive a physical exam, blood and urine tests, a
bone scan, a CT of the abdomen and pelvis, and an MRI scan of total body. On Day 1 of each
cycle patients will receive a physical exam and blood and urine tests. Bone scan, CT and MRI
scans will be performed at the start of cycles 3 and 5, and then repeated once every 12
weeks.
Patients will continue to receive study treatment as long as they are receiving benefit from
the treatment, do not experience any severe or unmanageable side effects, and disease does
not get any worse.
All cycles after that will be 42 days long. Patients will keep a diary to record study drug
dosing.
During the screening phase patients will receive a physical exam, blood and urine tests, a
bone scan, a CT of the abdomen and pelvis, and an MRI scan of total body. On Day 1 of each
cycle patients will receive a physical exam and blood and urine tests. Bone scan, CT and MRI
scans will be performed at the start of cycles 3 and 5, and then repeated once every 12
weeks.
Patients will continue to receive study treatment as long as they are receiving benefit from
the treatment, do not experience any severe or unmanageable side effects, and disease does
not get any worse.
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
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