Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01347788 |
Recruitment Status
:
Completed
First Posted
: May 4, 2011
Results First Posted
: November 17, 2015
Last Update Posted
: November 28, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Adenocarcinoma | Drug: cabozantinib | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
Dose level 0: cabozantinib 40 mg daily
|
Drug: cabozantinib
Cabozantinib PO QD
Other Name: XL84
|
Experimental: Cohort 2
Dose level -1: cabozantinib 20 mg daily
|
Drug: cabozantinib
Cabozantinib PO QD
Other Name: XL84
|
Experimental: Expansion cohort
Dose level 0: cabozantinib 40 mg daily
|
Drug: cabozantinib
Cabozantinib PO QD
Other Name: XL84
|
- Partial Response in Bone Scan From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]Bone scans will be centrally reviewed and categorized based on comparison of week 6 and baseline imaging. Partial response is defined as 30% or greater decrease in bone scan lesion area from baseline to week 6. An adaptive response design to determine the lowest effective cabozantinib dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347788
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Matthew R Smith, M.D., Ph.D. | Massachusetts General Hospital |
Publications of Results:
Responsible Party: | Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01347788 History of Changes |
Other Study ID Numbers: |
11-005 |
First Posted: | May 4, 2011 Key Record Dates |
Results First Posted: | November 17, 2015 |
Last Update Posted: | November 28, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Matthew R. Smith, MD, PhD, Massachusetts General Hospital:
Prostate cancer Castration Resistant Bone Metastases |
Additional relevant MeSH terms:
Prostatic Neoplasms Adenocarcinoma Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Prostatic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |