Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases
18 Years
N/A
Male
Prostate Adenocarcinoma
Trial Information
Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases
XL184 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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Post-Treatment change in bone scan from baseline to week 6
Outcome Description:
Bone scans will be centrally reviewed and categorized as complete resolution, significant improvement, stable disease, or unequivocal progression based on comparison of week 6 and baseline imaging. An adaptive response design to determine the lowest effective XL184 dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.
Outcome Time Frame:
Baseline and Week 6
Safety Issue:
No
Principal Investigator
Matthew R Smith, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Food and Drug Administration
Study ID:
11-005
NCT ID:
NCT01347788
Start Date:
April 2011
Completion Date:
May 2013
Related Keywords:
- Prostate Adenocarcinoma
- Prostate cancer
- Castration Resistant
- Bone Metastases
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
